Senior Specialist Quality Assurance Jobs At Bristol-Myers Squibb

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit ******************* or follow MMS on LinkedIn. This role is a project-based consulting opportunity to conduct vendor audits on an as-needed basis. This is not a full-time position. Responsibilities: Independently conduct GMP/GLP/GCP vendor qualification audits to include, but not limited to, manufacturing, labeling, packaging, analytical and/or clinical testing, or investigator sites Create audit related documents including audit plans and reports Collaborate with vendors and sponsors to plan and implement an audit schedule Oversee and monitor CAPA process Experience with hosting and interacting with regulatory authorities during an inspection Requirements: Minimum 10 years of experience in GMP/GLP/GCP auditing role within the CRO, Pharma, or Biotech industry Bachelor’s Degree in a scientific, medical or clinical discipline Travel required for onsite audits Experience with hosting and interacting with regulatory authorities during an inspection preferred Must be knowledgeable in 21 CFR Parts 11, 210, 211, and 820 Must have extensive experience auditing GMP, GLP, or GCP facilities including DP/DS and/or device manufacturing and QC or clinical laboratories, or investigator sites Expert knowledge of scientific principles and concepts Proficiency with MS Office applications Hands-on experience with clinical trial and pharmaceutical development Excellent communication skills and willingness to work with others to clearly understand needs and solve problems Excellent problem-solving skills Proficient experience with FDA and GMP/GLP/GCP requirements Basic understanding of CROs and scientific and clinical data/ terminology, and the drug development process Powered by JazzHR D1vIdQ2mYb

Job Description The QA Associate interprets and implements quality procedures, standards, and specifications for value streams, manages, and coordinates value stream QA activities, coordinates, and executes the review and approval of various quality programs, manages, and coordinates administrative functions within quality systems, performance management of direct reports, where applicable, and performs activities for process compliance and product release when required. Responsibilities: Provide technical and operational input on the operational planning of the unit and on the prioritization of objectives. Provide input into the budget and resource requirements of the section. Request and allocate assets and resources for the fulfillment of work objectives and monitor their use, current and future states. Provide section staff with day-to-day direction, tasks, and support area goals and objectives. Manage implementation of operational changes to SOPs and processes. Manage and coordinate process compliance activities to ensure that GMP documents are consistent with OTIF (On-Time and In-Full) with the planning schedule. Perform QA release for QA / GMP documents, as needed and as qualified for. Create, provide, and monitor the mentoring and training of group members to support external audits. needed. Create and maintain metrics/data to support decisions that will identify and mitigate risk, manage resource allocations, and identify opportunities for improvement. Provide QA approval on select Quality Assurance documents, across the Quality Unit. Perform other duties as assigned. Qualifications: Bachelor’s degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. 3-5 years of Quality Assurance experience in a GMP-regulated industry, such as pharmaceutical, biologics, medical devices, dietary supplements, food, cosmetics, or in combination with relevant education. Strong working knowledge of pharmaceutical quality management systems (e.g., Document Control, CAPAs, Deviations, Complaints, Change Control, etc.) Demonstrate familiarity with Lean Six Sigma Methodologies and proven analytical/ problem solving capabilities. Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates. Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision. Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required. Must be able to comprehend and follow all applicable SOPs. Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise. Able to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products. Good understanding of cGMPs, industry, and regulatory standards and guidelines. Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc. Demonstrate the ability to portray the appropriate level of integrity and professionalism. Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats. Demonstrate the ability to complete tasks accurately and according to established and shifting timelines. Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions. Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment. Results-oriented and efficient. Creative and open-minded who fosters an environment in which sharing of ideas is encouraged. Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally). Demonstrate the ability to work well in a cross-functional team environment. Must communicate fluently in English and have legible handwriting. Physical Demands: Ability to travel between and within facilities to visit staff, operations, and projects, as needed. Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary). Ability to lift up to 40 pounds on occasion. Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

The Quality Assurance (QA) Engineer II will play a key role in the implementation of Onkos Surgical's Quality Management System and have the opportunity to gain experience across a broad range of quality functions related ISO 13485 and 21 CFR Part 820 compliance. Specifically, the QA Engineer will champion complaint handling, product release procedures and approval, and support to both NCR and CAPA processes. This will require developing relationships and working closely with suppliers. This position will also work with cross-functional teams to provide quality engineering support in the development of technical files to ensure regulatory compliance during product development. Responsibilities Receive, document and process complaints related to product quality and patient safety. Conduct, coordinate and document complaint investigations. Review complaints for possible Adverse Events/MDRs and recommend regulatory reporting decisions. Prepare reports to regulatory agencies in a timely manner to meet regulatory deadlines. Review and approve Device History Records (DHRs) and communicate closely with contract suppliers to ensure compliance with Quality Agreements and QMS procedures. Participate in and support NCR and CAPA investigations. Participate in the application of statistical methods to trend NCRs, CAPAs, Complaints, and DHR approval acceptance. Support in Supplier vetting process and maintaining Approved Supplier List. Provide support to Product Development and Operations on design transfer and process validations. Participate in product risk assessment efforts, including failure mode effect analysis (FMEA's). Monitor quality metrics and key process indicators to identify opportunities. Lead and/or participate in multi-departmental initiatives to implement quality improvements. Drive compliance to the QMS and provide QMS training to appropriate team members. Author changes to existing procedures, work instructions, and forms as necessary. Comply with U.S. FDA and ISO requirements, other regulatory requirements, Company policies, operating procedures and processes. Perform other QA and quality control functions as necessary, with appropriate training. Assist in the review of Technical Files. Requirements Minimum of 5 years quality assurance experience in medical device industry. Manufacturing or supplier quality engineering experiences a plus. Working knowledge of CFR Part 820 and 13485 for medical device products. Complaint investigation experience. BS in an engineering discipline. Certified Quality Engineer certification a plus. Experience in root cause failure analysis and change control. Detail oriented and experience in a manufacturing environment a plus. Good verbal (including presentation) and written communication skills. About Onkos Surgical At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause. We exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients. At Onkos Surgical, we will: Find solutions to our patients' unmet clinical needs and advocate for their cause. Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently. Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance. Fulfill our employees' desire to make a difference in the lives of the patients they serve while achieving their own professional growth. Deliver value to our customers and shareholders.

Senior Manager, Quality Control Schedule: On-Site We are seeking an experienced and strategic leader to oversee Quality Control operations across multiple manufacturing sites. This role is responsible for managing 24/7 in-process testing, raw material and finished product release, stability programs, and microbiological testing. The Senior Manager will drive compliance, operational excellence, and continuous improvement within a regulated pharmaceutical environment. Key Responsibilities Ensure timely testing and data release to meet service and compliance targets Lead stability testing programs, ensuring 100% on-time execution of all scheduled intervals Serve as the primary point of contact for analytical method transfers into QC Manage and develop a cross-functional team of managers, supervisors, and analysts Provide leadership on cGMP compliance and quality system enhancements Act as Subject Matter Expert during internal and external audits Implement Lean and Six Sigma tools to optimize QC processes Standardize analytical methods to improve consistency and usability in lab settings Collaborate with manufacturing and R&D on validations, campaigns, and special projects Promote a strong safety culture and ensure compliance with EHS standards Oversee compendial compliance and QC system administration Qualifications Education: Bachelor's degree in Chemistry, Chemical Engineering, or a related scientific field (or equivalent experience) Experience: 10+ years in pharmaceutical Quality Control or Quality Assurance Proven leadership in managing teams and complex projects In-depth knowledge of cGMP, GLP, and GXP regulations

Key Responsibilities: Develop, implement, and maintain CAPA processes in compliance with FDA 21 CFR Part 820 and ISO 13485 standards. Conduct thorough investigations to identify root causes of nonconformities and quality issues. Collaborate with cross-functional teams to develop and implement effective corrective and preventive actions. Monitor and analyze quality data to identify trends and areas for improvement. Prepare and present CAPA reports to management and regulatory bodies. Provide training and guidance to staff on CAPA processes and best practices. Ensure timely closure of CAPAs and verify the effectiveness of implemented actions. Support internal and external audits related to CAPA processes. Process non-conforming products, execute identified corrective actions, update procedures, and support production in a team setting. Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field (preferred but not required). Minimum of 2 years of experience in quality management within the medical device industry. In-depth knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 standards. Proven experience in managing CAPA processes and conducting root cause analysis. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Certification in Quality Management (e.g., ASQ CQE, CQA) is a plus. Familiarity with Microsoft Office Suite. Preferred Skills: Experience with quality management software and tools. Familiarity with risk management principles and practices. Project management experience. Ability to prioritize work and execute projects/actions with minimal guidance. Quick learner with an understanding of the medical device field. Desired Skills and Experience Key Responsibilities: Develop, implement, and maintain CAPA processes in compliance with FDA 21 CFR Part 820 and ISO 13485 standards. Conduct thorough investigations to identify root causes of nonconformities and quality issues. Collaborate with cross-functional teams to develop and implement effective corrective and preventive actions. Monitor and analyze quality data to identify trends and areas for improvement. Prepare and present CAPA reports to management and regulatory bodies. Provide training and guidance to staff on CAPA processes and best practices. Ensure timely closure of CAPAs and verify the effectiveness of implemented actions. Support internal and external audits related to CAPA processes. Process non-conforming products, execute identified corrective actions, update procedures, and support production in a team setting. Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field (preferred but not required). Minimum of 2 years of experience in quality management within the medical device industry. In-depth knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 standards. Proven experience in managing CAPA processes and conducting root cause analysis. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Certification in Quality Management (e.g., ASQ CQE, CQA) is a plus. Familiarity with Microsoft Office Suite. Preferred Skills: Experience with quality management software and tools. Familiarity with risk management principles and practices. Project management experience. Ability to prioritize work and execute projects/actions with minimal guidance. Quick learner with an understanding of the medical device field.

Senior QA - Compliance & Inspection Management George Higginson is currently searching for an experienced Senior QA Specialist, with experience in both Compliance and Inspection Management, for a Biologics specialist CDMO. The incumbent is responsible for supporting site management ensuring the site performs in a state of compliance by supporting all Quality Compliance and Inspection Management oversight activities while fostering an empowered culture of quality across all functions Main Responsibilities: Author, review, and approve SOPs, protocols, and quality records to ensure compliance with regulations and international standards. Evaluate Quality Systems and procedures, identifying areas for improvement and supporting process enhancements. Assist with GMP training, internal/external audits, and maintaining the customer audit process. Support audit and inspection activities (Client, Internal, Regulatory) and lead backroom activities during audits. Coordinate and track risk assessments, Quality metrics, and discrepancy reports (e.g., deviations, CAPAs, complaints). Maintain and manage Electronic Management Systems related to Quality. Communicate effectively with team members and contribute as a collaborative team player. Travel as needed for audits, conferences, and training opportunities. Adhere to quality standards, company policies, and ethical guidelines while maintaining professionalism. Requirements: Between 5-10 years of experience in a GMP-regulated biopharmaceutical facility or equivalent. Minimum of a B.S. degree in Life Sciences or a related discipline. Strong knowledge of industry standards and regulatory requirements for biologics and parenteral products in clinical development and commercial stages. Proficiency in GMP regulations (US, EU, and ROW), good documentation practices, cGMP, 21 CFR, USP, and other applicable standards and guidance. Detail-oriented with excellent analytical, written, and verbal communication skills. Familiarity with Microsoft Office applications. Ability to work well under pressure, independently manage multiple tasks, and maintain organization with strong communication skills. This is a fantastic opportunity to be a key part of a cutting-edge CDMO, helping to shape the future of the organization while ensuring the delivery of top-quality products in a safe and compliant environment. Apply today to take the next step in your leadership journey!

Schedules Team Members for specific areas within Entertainment. Provides support to department management related to scheduling and timesheets, and interfaces with Payroll on the department’s behalf. Maintains scheduling database records and provides support to database users. Acts as a resource for others in the division as it relates to scheduling and specific pay practices/policies. MAJOR RESPONSIBILITIES: Completes a weekly schedule for assigned areas using a scheduling database. Balances business needs and Team Member availability to provide schedules that minimize overtime and report pay. Maintains and adjusts schedules per Policy/Procedure, as needed, based on attendance levels, special events, and other factors. Utilizes accurate set credit work rules and Entertainment-specific pay policies/practices as it relates to the distribution of hours and Performance Pay. Works with departmental management to ensure Team Members are utilized in the proper roles and provide recommendations for additional training to increase skill base. Assists in the compilation of venue labor information. Assists departmental management on updates of schedule assists and rollouts as needed. Provides historic training data to managers as needed. Coordinates with other departments/divisions to ensure Team Member schedules and pay follow Entertainment-specific policies/procedures. Ensures that established Entertainment-specific Policies/Practices relating to scheduling and timecards are being followed, and escalates issues as necessary. Assists with the weekly review of Team Member time sheets. Generates and reviews appropriate reports for validating pay policy/practice information in Timekeeping software. Examples of reporting data may include but are not limited to last day worked, contracted vs worked hours, benefit validation, and distribution of hours. Retrieves records as needed. Responds to questions posed by Management and Team Members relating to scheduling and specific Entertainment pay practices/policies. Investigates and completes payroll adjustments received from Management to ensure accuracy and need. Submits the adjustment for Departmental approval. May be responsible for processing schedule swaps, directing and onboarding new hires, scheduling classes, and training opportunities. Provides information and records relating to Team Member general information, account codes, position codes, skill codes, and account numbers. Ensures integrity of data through periodic review. Provides assistance to Timekeeping software users on intricacies of the software as it directly relates to the Entertainment division's superuser access and troubleshooting errors within the system. Reports system issues appropriate IT partners. Assists with training new Team Members on scheduling, and Entertainment-specific pay practices/policies. Assists in testing Timekeeping software and upgrades, as needed, and recommends corrective action based on defined department policies/procedures. Understands and actively participates in Environmental, Health & Safety responsibilities by following established UO policy, procedures, training and team member involvement activities. Performs other duties as assigned. EDUCATION: High school degree or GED required. EXPERIENCE: 2+ years’ experience within the professional entertainment or theme park industry preferred; or equivalent combination of education and experience. Must be able to demonstrate ability to type 30 words per minute and proficiency with 10-key and/ or Microsoft Office programs ADDITIONAL INFORMATION: Proficiency in MS Office systems is required. Familiarity with Universal Orlando systems is a plus. Strong analytical and organizational skills. Strong communication skills with a high degree of tact. Strong multi-tasking skills. General working knowledge of computers and office software. Ability to interact professionally with multiple internal and external partners. Ability to perform work on multiple, diverse assignments simultaneously. Ability to sort through large quantities of data with moderate levels of complexity. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Consistent attendance is a job requirement. Your talent, skills and experience will be rewarded with a competitive compensation package. Universal is not accepting unsolicited assistance from search firms for this employment opportunity. All resumes submitted by search firms to any employee at Universal Orlando via-email, the Internet or in any form and/or method without a valid written Statement of Work in place for this position from Universal Orlando HR/Recruitment will be deemed the sole property of Universal Orlando. No fee will be paid in the event the candidate is hired by Universal Orlando as a result of the referral or through other means. Universal Orlando Resort. Here you can. Universal Orlando is an equal opportunity employer. Universal elements and all related indicia TM & © 2025 Universal Studios. All rights reserved. EOE

The Senior Manager of Quality Assurance is responsible for managing a staff of quality assurance personnel for day-to-day quality operations within the Quality Control (QC) (Analytical and Microbiology) laboratory operations. Assures Quality oversight of QC laboratory testing, and ensures testing meets applicable standards and regulations requirements for product and materials. Ensures adherence to facility quality systems such as batch review, product release, change control, deviation and CAPA management, and product annual reviews. Manages resources to ensure production cycle times are met for manufacturing, supply chain and client demands. Oversees the design, development and implementation of laboratory QA programs, and ensures all cGMP requirements, including review of QC data, lab investigation, and compliance to data integrity principles. PRINCIPAL DUTIES: · Manages quality assurance personal for day-to-day operations for QC labs. · Manages, trains and develops direct reports. · Manages resources in order to meet annual budget. Reviews new project requirements ensuring QA or QA project plans are prepared as needed. · Manages resources to ensure adequate product/material cycle times are met in order to meet supply chain and client demands. · Implements LEAN concepts to continuously improve cycle times within the area of responsibility. · Partners with QC management in the areas of cGMP compliance and quality systems. · Provides direction in the event of QC incidents that may potentially affect quality or compliance. · Manages investigations, CAPAs, QC record review, product release CofA, Environmental Monitoring data, change control, requalification and product annual review in the QC area. · Reviews and approves changes within the QC area including changes to process, equipment, procedures, and computerized systems. · Reviews raw data, to verify that ALCOA++ principles are being followed, accurate and in control before reporting. · Reviews control charts and records on instrument calibration and performance of known and blind QA samples as a measure of analytical precision and accuracy. · Ensures compliance with current regulatory or product license requirements and cGMPs. · Maintains appropriate records, certifications and training verification for ongoing laboratory programs and operations. · Ensures that all applicable SOPs and QA Manuals are revised, updated, and implemented as required. · Supports the Pyramid facility during external and regulatory inspections. · Works directly with the investigators on defending facility quality systems and QC Lab investigations (e.g., OOT, OOS, etc.). · Leads and performs technical write-up in support of deviation investigations pertaining to Lab QA Roles and Responsibilities. · Performs other duties as assigned. JOB REQUIREMENTS: · Demonstrates proficiency in multiple quality systems including Deviation, CAPA and Out-of-Specification management, Change Control, Document Control, Product Testing Review and Release, Supplier Quality, etc. with strong decision-making skills utilizing risk management. · Experience in all facets of QC operations including but not limited to utilities, raw materials, in-process, and final container testing. · Strong biologics production experience · Strong Materials/Component experience · Lead multiple tasks/projects within timelines · Strong verbal, written and oral communication skills. Able to present business indicators to senior management · Strong knowledge of cGMP (US, EU, Canadian, Japan) required · Strong knowledge of manufacturing processes, laboratory operations and/or critical systems required · Able to present areas of responsibility to regulatory agencies during inspections · Proficient in problem solving through the use of continuous improvement tools. · Able to use continuous improvement tools; certification desired in ASQ, Green Belt, Lean, or equivalent · Able to manage employees, conduct performance reviews, establish development plans and manage resources · Must have: o Integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction. o Passion to innovate and drive for solutions. o Uncompromising dedication to quality. o Relentless focus on rapid and disciplined action. o Respect for individuals and the diverse contributions of all. o Must display personal accountability for results and integrity. o Must display eagerness to learn and continuously improve. · Must display o Personal accountability for results and integrity. o Eagerness to learn and continuously improve. EDUCATION and/or EXPERIENCE: · Bachelor's degree in Sciences or Engineering. · Minimum 10 years' experience in Quality Operations function in a biotechnology, biologics, or pharmaceutical manufacturing facility, with 5 years' experience overseeing Quality Control Lab QA functions. · Minimum 8 years previous leadership, supervisory or management experience required. · Quality Drug Product experience, preferred

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring a Quality Assurance Specialist at Wake Research, an M3 company. This is a remote position with up to 40% travel. The Quality Assurance Specialist will conduct comprehensive quality assurance reviews in support of M3 Wake Research's clinical teams. This role involves collaborating with clinical research staff to address findings, provide recommendations for improvement, and ensure compliance within their area of expertise. The Quality Assurance Specialist will oversee audits and inspections, and work cross-functionally to support continuous quality enhancement across the organization. Essential Duties and Responsibilities: Including, but not limited to the following: Travel to M3 Wake Research sites to conduct internal quality assurance reviews of clinical trials and processes for adherence to SOPs, company policy, and regulations/standards. Prepare reports and discuss non-compliance and/or quality findings with internal customers as well as with Quality management. Track and follow up on the resolution of review findings. Provide guidance to clinical staff in resolving findings, implementing processes, and CAPA plans to include development, root case analysis, implementation, and evaluation of CAPA plans. Work closely with assigned clinical teams and site directors to identify gaps and ensure continuous process improvement in conjunction with Quality management. Assist in preparing for inspections by sponsors and regulatory agencies and participate in on site regulatory inspections as appropriate. Assist in implementing quality management plans including risk identification and assessment through data review and quality control processes. Provides consultation on corrective and preventive actions performed as a result of observations; follows-up and provides data required to determine the timeliness and effectiveness of corrective and preventive actions performed by the site staff and operational team. Assist with the development or enhancement of training materials. Conducts on-the-job training (OJT) and instructor-led training (ILT) for employees and new hires. Conduct review of training records to ensure assigned sites are maintaining compliance with training curriculum. Remain informed about developments in relevant clinical trial requirements, FDA, ICH, GCP, and guidelines within the US and other regions, as appropriate for M3 Wake Research. Identify and escalate significant compliance issues. Share quality topics and lessons learned to the organization. Assist individual sites in development of internal guidance documents to supplement corporate SOPs. Assist with quality incident and compliance investigations. Qualifications Bachelor's degree or equivalent experience Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA), applicable regulatory requirements, and quality management processes. 3-5 years prior work experience in a clinical quality, clinical compliance, or clinical auditing role. Direct experience in the conduct and reporting of internal and external audits preferred. Experience preparing for, participating in, and subsequent response to health authority GCP inspections/partner audits also preferred. Clinical Research or Quality Certification preferred. Excellent interpersonal, verbal, and written communication skills. Client focused approach. Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills. Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization. Proficient in Microsoft Office programs such as MS Word, Outlook, Excel, PowerPoint, SharePoint, and Teams. Fully and consistently able to demonstrate tact, diplomacy, discretion, and good judgment. Additional Information About M3USA M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Remote #LI-LB1

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring a Quality Assurance Specialist at Wake Research, an M3 company. This is a remote position with up to 40% travel. The Quality Assurance Specialist will conduct comprehensive quality assurance reviews in support of M3 Wake Research's clinical teams. This role involves collaborating with clinical research staff to address findings, provide recommendations for improvement, and ensure compliance within their area of expertise. The Quality Assurance Specialist will oversee audits and inspections, and work cross-functionally to support continuous quality enhancement across the organization. Essential Duties and Responsibilities: Including, but not limited to the following: Travel to M3 Wake Research sites to conduct internal quality assurance reviews of clinical trials and processes for adherence to SOPs, company policy, and regulations/standards. Prepare reports and discuss non-compliance and/or quality findings with internal customers as well as with Quality management. Track and follow up on the resolution of review findings. Provide guidance to clinical staff in resolving findings, implementing processes, and CAPA plans to include development, root case analysis, implementation, and evaluation of CAPA plans. Work closely with assigned clinical teams and site directors to identify gaps and ensure continuous process improvement in conjunction with Quality management. Assist in preparing for inspections by sponsors and regulatory agencies and participate in on site regulatory inspections as appropriate. Assist in implementing quality management plans including risk identification and assessment through data review and quality control processes. Provides consultation on corrective and preventive actions performed as a result of observations; follows-up and provides data required to determine the timeliness and effectiveness of corrective and preventive actions performed by the site staff and operational team. Assist with the development or enhancement of training materials. Conducts on-the-job training (OJT) and instructor-led training (ILT) for employees and new hires. Conduct review of training records to ensure assigned sites are maintaining compliance with training curriculum. Remain informed about developments in relevant clinical trial requirements, FDA, ICH, GCP, and guidelines within the US and other regions, as appropriate for M3 Wake Research. Identify and escalate significant compliance issues. Share quality topics and lessons learned to the organization. Assist individual sites in development of internal guidance documents to supplement corporate SOPs. Assist with quality incident and compliance investigations. Qualifications Bachelor’s degree or equivalent experience Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA), applicable regulatory requirements, and quality management processes. 3-5 years prior work experience in a clinical quality, clinical compliance, or clinical auditing role. Direct experience in the conduct and reporting of internal and external audits preferred. Experience preparing for, participating in, and subsequent response to health authority GCP inspections/partner audits also preferred. Clinical Research or Quality Certification preferred. Excellent interpersonal, verbal, and written communication skills. Client focused approach. Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learning. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail and strong organizational skills. Ability to work effectively in a matrix environment and to demonstrate and foster teamwork within the group as well as across the organization. Proficient in Microsoft Office programs such as MS Word, Outlook, Excel, PowerPoint, SharePoint, and Teams. Fully and consistently able to demonstrate tact, diplomacy, discretion, and good judgment. Additional Information About M3USA M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Remote #LI-LB1

The QA Investigation Specialist plays a critical role in maintaining compliance and ensuring the integrity of manufacturing operations by executing thorough and timely investigations into deviations-primarily within downstream biologics processes. This individual will lead and support root cause analysis efforts, drive effective CAPA implementation, and collaborate across functional teams to uphold GMP standards and continuous improvement. Key Responsibilities: * Lead the end-to-end investigation and closure of deviations, including minor, major, and critical events, originating from manufacturing operations-especially focused on downstream biologics processes. * Perform real-time deviation triage and provide quality oversight for immediate containment actions and initial impact assessments. * Utilize advanced Root Cause Analysis (RCA) methodologies (e.g., 5 Whys, Fishbone, Fault Tree) to identify true root causes and contributing factors. * Author comprehensive and compliant investigation reports in alignment with internal SOPs and regulatory expectations (FDA, EMA, etc.). * Develop and implement robust, data-driven Corrective and Preventive Actions (CAPAs) to eliminate recurrence and enhance process robustness. * Achieve and sustain >80% Right First Time (RFT) rate on deviation documentation and review cycle times within defined KPIs. * Partner cross-functionally with Manufacturing, MS&T, Quality Control, and Engineering teams to gather data, analyze process trends, and ensure a holistic approach to investigations. * Manage and prioritize multiple deviation cases and CAPA projects simultaneously while meeting strict deadlines. * Facilitate investigation review meetings, present findings to stakeholders, and effectively manage differing viewpoints to drive consensus. * Support audit and inspection readiness by maintaining thorough documentation and assisting with walkthroughs, interviews, and response preparation. * Contribute to continuous improvement initiatives related to deviation and CAPA management systems. * Perform additional QA-related duties as assigned to support the overall quality management system.

The QA Investigation Specialist plays a critical role in maintaining compliance and ensuring the integrity of manufacturing operations by executing thorough and timely investigations into deviations-primarily within downstream biologics processes. This individual will lead and support root cause analysis efforts, drive effective CAPA implementation, and collaborate across functional teams to uphold GMP standards and continuous improvement. Key Responsibilities: Lead the end-to-end investigation and closure of deviations, including minor, major, and critical events, originating from manufacturing operations-especially focused on downstream biologics processes. Perform real-time deviation triage and provide quality oversight for immediate containment actions and initial impact assessments. Utilize advanced Root Cause Analysis (RCA) methodologies (e.g., 5 Whys, Fishbone, Fault Tree) to identify true root causes and contributing factors. Author comprehensive and compliant investigation reports in alignment with internal SOPs and regulatory expectations (FDA, EMA, etc.). Develop and implement robust, data-driven Corrective and Preventive Actions (CAPAs) to eliminate recurrence and enhance process robustness. Achieve and sustain >80% Right First Time (RFT) rate on deviation documentation and review cycle times within defined KPIs. Partner cross-functionally with Manufacturing, MS&T, Quality Control, and Engineering teams to gather data, analyze process trends, and ensure a holistic approach to investigations. Manage and prioritize multiple deviation cases and CAPA projects simultaneously while meeting strict deadlines. Facilitate investigation review meetings, present findings to stakeholders, and effectively manage differing viewpoints to drive consensus. Support audit and inspection readiness by maintaining thorough documentation and assisting with walkthroughs, interviews, and response preparation. Contribute to continuous improvement initiatives related to deviation and CAPA management systems. Perform additional QA-related duties as assigned to support the overall quality management system. Requirements Qualifications: Bachelor's degree in Life Sciences, Engineering, or a related discipline required; advanced degree preferred. Minimum 4-7 years of experience in GMP-regulated biologics or pharmaceutical manufacturing environment, with a strong focus on quality investigations. Proven expertise in deviation management, CAPA, and root cause analysis tools. Familiarity with electronic quality management systems (e.g., Veeva, TrackWise) and batch record review processes. Excellent written and verbal communication skills, with the ability to clearly articulate complex technical findings. Strong interpersonal skills and a collaborative mindset. Benefits Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays)

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods. QA Batch Record Specialist role supports fast-paced production environment to ensure controlled documents are managed as per standard processes and that product quality meets internal and regulatory requirements for release. Work schedule: Monday - Thursday 5:30a - 4:00p High School diploma or GED required; higher learning certifications in an area relevant to role preferred. Minimum one (1) year of experience in a FDA-regulated manufacturing facility. Ability to read and interpret documents in English. Ability to perform calculations in all units of measure and understand rounding rules, significant figures, and tolerances to determine compliance with established criteria. Ability to use PC, calculator, and basic software (i.e., Microsoft Office); GMP software (e.g., Agile PLM, Oracle) experience preferred. Ability to read and follow written policies/procedures for cGMP, SOP, and Safety guidelines. Must be detail-oriented and organized to work in a fast-paced environment and adapt to changing priorities to meet operations demands. Ability to work both independently and as a member of a team. Strong interpersonal skills to communicate effectively with all departments at all levels within the organization via multiple communication mediums. POSITION RESPONSIBILITIES : Maintain professional, respectful and positive work environment. Practice acute attention to detail, high level of organization, and error-free performance in all tasks while supporting a fast-paced environment and adapting to changing priorities to meet operations demands. Generate controlled documents (e.g., logbooks, bulk compounding batch records, finished good batch records) for issuance using the Warehouse Management System (i.e., Oracle) and/or Quality Management System (i.e., Agile) as per the current production schedule and/or requests. Document transactions related to controlled document issuance, remittance, review, and release in shared logbooks and trackers as required. Document metrics related to processing batch records for release in shared tracker as required. Communicate with other departments regarding document control activities to ensure timely completion of tasks to support operations and release of finished goods. Review controlled documents (primarily batch records) returned/submitted to Document Control for completeness and correctness to ensure compliance with internal and regulatory criteria; facilitate resolution of observations (e.g., corrections) before release of finished goods and archival of documents. Place and remove product on QA hold when required; ensure Quality Events are resolved and verify disposition to manage bulk and finished goods accordingly. Change product status and close jobs in Warehouse Management System for release of finished goods. Upload required documents (e.g., batch records, customer-required documents) to appropriate shared file locations as required. Maintain the filing system for controlled document archival and destruction as per standard processes; retrieve controlled documents as requested for inspection. Assist with batch-related investigations as requested. Responsible for training employees in OJT, provided you have demonstrated a proficient understanding of the internal and regulatory requirements for each product category. Other reasonable business-related duties as necessary. PHYSICAL REQUIREMENTS: Ability to lift up to 25 pounds. Adequate vision to read controlled documents accurately. BENEFITS: PLD is a proud equal opportunity employer offering many corporate benefits, including: ⠁ Medical and Dental Benefits ⠁ 401K with employer match ⠁ Group Life Insurance ⠁ Flex Spending Accounts ⠁ Paid Time Off and Paid Holidays ⠁ Tuition Assistance ⠁ Corporate Discount Program ⠁ Opportunities to Flourish Within the Company PL Developments is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. #HP1

Nature and Scope Reporting to the QA Compliance Program Manager, the Compliance Program Specialist II focuses on facilitating Compliance and CAPA System activities at American Regent. This is a multi-disciplinary role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at all American Regent Sites in Ohio. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. * Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. * Responsible for executing and maintaining Internal Audit Program. Work with Functional Area Management and cross-functional teams to ensure procedural compliance and alignment with internal, regulatory, and corporate requirements. * Responsible for executing and maintaining Compliance Corrective Action and Preventive Action (CAPA) System. Work with owners and cross-functional teams to ensure appropriate Corrective Action Plans are implemented and verified for effectiveness in accordance with company SOPs, policies, and cGMPs and escalate when necessary. * Responsible for executing and maintaining Customer Complaints Program in Ohio including metric reporting. Works with functional areas to investigate and ensure timely closure of Customer Complaints. * Responsible for executing and maintaining Gap Assessment program, ensuring procedural compliance and alignment with regulatory (domestic and foreign) compendia, and corporate requirements. * Responsible for executing and maintaining inspection readiness program including participation in 'tactical room' for regulatory and customer audits. * Continually collect and maintain presentation of Quality Systems reports/metrics to Senior Management at defined frequencies. * Participate in Continuous improvement portfolio activities as it relates to Compliance. This may involve cross functionality of areas from QA, QC, OPS, and may require application of statistical concepts and methodologies. * Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. * Bachelors in Life Science, Statistics or related field required or equivalent years of experience * Minimum of 3 years of work experience in QA, Regulatory Compliance or Pharmaceutical Operations in a cGMP manufacturing environment is required. * Experience across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facilities; review and release of cGMP production batches. * Knowledge of US regulations and established expertise in interpreting and applying to organization is required. * General knowledge of overall statistical concepts and Six Sigma Green Belt certification is preferred. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. * FMLA poster: ********************************************************** * Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) * Employee Polygraph Protection Act: ********************************************************* American Regent Inc. endeavors to make ********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Nature and Scope Reporting to the QA Compliance Program Manager, the Compliance Program Specialist II focuses on facilitating Compliance and CAPA System activities at American Regent. This is a multi-disciplinary role that will interact with all phases of production including manufacture of sterile injectables, laboratories, facilities/engineering, and materials at all American Regent Sites in Ohio. Essential Duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Perform all duties in accordance with American Regent and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines. Responsible for executing and maintaining Internal Audit Program. Work with Functional Area Management and cross-functional teams to ensure procedural compliance and alignment with internal, regulatory, and corporate requirements. Responsible for executing and maintaining Compliance Corrective Action and Preventive Action (CAPA) System. Work with owners and cross-functional teams to ensure appropriate Corrective Action Plans are implemented and verified for effectiveness in accordance with company SOPs, policies, and cGMPs and escalate when necessary. Responsible for executing and maintaining Customer Complaints Program in Ohio including metric reporting. Works with functional areas to investigate and ensure timely closure of Customer Complaints. Responsible for executing and maintaining Gap Assessment program, ensuring procedural compliance and alignment with regulatory (domestic and foreign) compendia, and corporate requirements. Responsible for executing and maintaining inspection readiness program including participation in ‘tactical room' for regulatory and customer audits. Continually collect and maintain presentation of Quality Systems reports/metrics to Senior Management at defined frequencies. Participate in Continuous improvement portfolio activities as it relates to Compliance. This may involve cross functionality of areas from QA, QC, OPS, and may require application of statistical concepts and methodologies. Perform any other tasks/duties as assigned by management. Education Requirements and Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Bachelors in Life Science, Statistics or related field required or equivalent years of experience Minimum of 3 years of work experience in QA, Regulatory Compliance or Pharmaceutical Operations in a cGMP manufacturing environment is required. Experience across multiple areas including developing quality system requirements for cGMP compliance of pharmaceutical drug production and laboratory facilities, validation for pharmaceutical manufacturing facilities; review and release of cGMP production batches. Knowledge of US regulations and established expertise in interpreting and applying to organization is required. General knowledge of overall statistical concepts and Six Sigma Green Belt certification is preferred. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: ********************************************************** Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: ********************************************************* American Regent Inc. endeavors to make ********************************** accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email **************************************.

Job Description STAQ Pharma is currently hiring for a Quality Assurance Specialist to join our team here in Denver for our 1st shift. Effectively encourage and motivate associates to be successful and remain focused on Quality, Transparency, Safety and Availability objectives compatible with the company’s mission and vision. Responsible for providing oversight of the Quality System; including managing control of documents (SOPs, WI, Specifications, Batch Records, etc.) that impact the identity, strength, quality, and purity of finished product, and providing support on Quality management projects. Schedule: Monday to Friday 6 AM Until Done Duties/Responsibilities: Lead the document control program to ensure procedures meet CGMP requirements Manage training documentation and track employee compliance with training plans Issue GMP documents including Master Batch Production Records, Room and Equipment Logs, Document Change Orders, etc. Support in-process and finished product lot acceptance sampling and inspection Participate in investigations and problem solving of raw material, in-process, and finished product non-conformances with production personnel and/or supplier Develop and implement corrective and preventive actions geared toward continuous process improvements Support the finished product label printing and issuance process Write and implement standard operating procedures to meet and maintain FDA cGMP, USP, and state licensure requirements Provide supplier related support to production and receiving inspection team Other duties and tasks, as assigned Required Skills/Abilities: Excellent independent judgement and interpersonal skills Excellent mathematical, written communication, and verbal communication skills Strong technical writing skills and attention to detail Knowledge of and proficiency in the use of basic statistics Familiarity with Good Manufacturing Practices and FDA Regulations Supplier Auditing experience Knowledge of ERP System Proficient in using Microsoft Word, Excel, PowerPoint, Outlook: experience with OneNote and Publisher a plus Education and Experience: 2-5 years of Quality Assurance experience Pharmaceutical, Medical Device, or biotechnology industry experience, preferably in support of manufacturing B.S. or B.A. on Sciences or a relevant field or equivalent experience Professional certification in Quality Engineering or Quality Auditing, preferred Physical Requirements: Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times.

The Senior Manager, Quality Assurance Contamination Control and Sterility Assurance is recognized as having expertise in the principals and application of sterility assurance and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing. This role will partner with stakeholders to define strategies for contamination control activities in key areas that include facility and equipment design and qualification (e.g. cleanroom, isolators, autoclaves, etc.), environmental qualification and monitoring programs, and operational practices (e.g. gowning, cleaning and sanitization, etc.). This individual will interface with internal manufacturing sites to support the maintenance of critical cGMP contamination control activities and provide technical support for the overall contamination strategy and facility monitoring programs. The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs. In addition, the successful candidate will be experienced in the fields of sterility assurance, microbial testing, environment and critical utilities monitoring programs, and in the design, commissioning, and qualification of facilities, utilities, and equipment systems. This role will report to the Senior Manager, Quality Assurance Contamination Control and Sterility Assurance within the Vertex Cell and Genetics Therapies QA group. Key Duties and Responsibilities: * Driving Sterility Assurance: * Maintain and support the site Contamination Control Strategy (CCS), managing gap assessments and risk assessments related to Annex 1 and Global GMP guidelines. * Conducting risk assessments for aseptic processes, environmental monitoring, facilities and other interrelated systems to mitigate contamination risks. * Leading initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments. * Establish and maintain analytics and KPI reporting methods for site Contamination Control performance. * Support review and approval of APS Process-Specific Master Batch Records (MBRs) * Consult as SME for Deviations during APS execution * Oversight of Environmental Monitoring and Contamination Control: * Managing and optimizing the environmental monitoring program, ensuring it effectively supports aseptic manufacturing and mitigates contamination risks. * Investigating out-of-specification results (deviations) in environmental monitoring, manufacturing, identifying root causes, and implementing corrective actions to prevent recurrence. * Overseeing the implementation and effectiveness of contamination control measures, including cleaning and disinfection practices. * Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement. * Sterility Related Validation: * Leading the scheduling and oversight of aseptic process simulations (media fills) and providing guidance during execution, report reviews and approvals. * Validating and revalidating sterility-related test methods and aseptic processes to ensure compliance and robustness. * Representing the sterility assurance function in internal and external audits, addressing observations related to sterility, and driving responses and actions. * Leadership and Collaboration: * Support a multidisciplinary team to achieve sterility assurance objectives, providing training on aseptic and contamination control principles. * Support/lead monthly contamination control committee providing technical analysis regarding EM performance and system health. * Working cross-functionally with Quality, Quality Control, Manufacturing, Validation and Engineering teams to ensure alignment on sterility assurance requirements. * Acting as a key advisor to manufacturing teams, supporting investigations and CAPAs for sterility-related deviations. * Lead or support quality investigations, risk assessments, and CAPA development. Ensure all quality records are scientifically sound, closed on time, and aligned with regulatory expectations and internal policies. * Documentation and Reporting: * Approving and maintaining documentation, including SOPs, validation protocols, contamination control plans, and trend reports. * Tracking and reporting contamination control performance metrics to identify areas for improvement and enhance contamination control strategies. * Write and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews. * Support inspection readiness plans and interact with regulatory agencies during inspections on contamination control related subject matter. * Assess Impact to CCS as the functional area owner per Change Management * GMP Qualification * Supporting the qualifications of isolators, and other clean air equipment. * Supporting the qualifications of cleanrooms including aspects such as Cleanroom Recovery, Airflow Visualization and Environmental Classification. * Supporting the qualification of critical utilities including Compressed Gas(s) and WFI systems. Education and Experience: * ·Educational Background: Minimum of a Bachelor's degree is preferred in Microbiology, Biotechnology, or a related discipline. * Work experience: 6-10 years of sterility assurance/contamination control or GMP experience (Commercial preferred). * Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits. * Aseptic Process Expertise: o Proven experience in contamination control strategies o Proven experience with clean air equipment, environmental monitoring, and aseptic processing simulations. * Leadership Skills: Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives. * Risk Assessment & Problem-Solving: Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive actions. * Technical Proficiency: Proficient in the use of contamination control tools, monitoring systems, including LIMS, Excel, and project management software. We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work: 1. Hybrid and work remotely up to two days per week; or select 2. On-Site and work 5 days per week with ad hoc flexibility. #LI-AR1 #LI-Hybrid Pay Range: $124,800 - $187,200 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

divp style="text-align:left"bJob Description/b/pp The Senior Manager, Quality Assurance Contamination Control and Sterility Assurance is recognized as having expertise in the principals and application of sterility assurance and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing. This role will partner with stakeholders to define strategies for contamination control activities in key areas that include facility and equipment design and qualification (e. g. cleanroom, isolators, autoclaves, etc. ), environmental qualification and monitoring programs, and operational practices (e. g. gowning, cleaning and sanitization, etc. ). This individual will interface with internal manufacturing sites to support the maintenance of critical cGMP contamination control activities and provide technical support for the overall contamination strategy and facility monitoring programs. /pp/pp The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs. In addition, the successful candidate will be experienced in the fields of sterility assurance, microbial testing, environment and critical utilities monitoring programs, and in the design, commissioning, and qualification of facilities, utilities, and equipment systems. /pp/pp This role will report to the Senior Manager, Quality Assurance Contamination Control and Sterility Assurance within the Vertex Cell and Genetics Therapies QA group. /pp/pp/ppb Key Duties and Responsibilities:/b/pullipbspan Driving Sterility Assurance:/span/b/p/lilispan Maintain and support the site Contamination Control Strategy (CCS), managing gap assessments and risk assessments related to Annex 1 and Global GMP guidelines. /span/lilispan Conducting risk assessments for aseptic processes, environmental monitoring, facilities and other interrelated systems to mitigate contamination risks. /span/lilispan Leading initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments. /span/lilispan Establish and maintain analytics and KPI reporting methods for site Contamination Control performance. /span/lilispan Support review and approval of APS Process-Specific Master Batch Records (MBRs)/span/lilispan Consult as SME for Deviations during APS execution/span/lilipbspan Oversight of Environmental Monitoring and Contamination Control:/span/b/p/lilispan Managing and optimizing the environmental monitoring program, ensuring it effectively supports aseptic manufacturing and mitigates contamination risks. /span/lilispan Investigating out-of-specification results (deviations) in environmental monitoring, manufacturing, identifying root causes, and implementing corrective actions to prevent recurrence. /span/lilispan Overseeing the implementation and effectiveness of contamination control measures, including cleaning and disinfection practices. /span/lilispan Perform regular GEMBA style assessments of manufacturing operations including identification of deficiencies and opportunities for improvement. /span/lilip/ppbspan Sterility Related Validation:/span/b/p/lilispan Leading the scheduling and oversight of aseptic process simulations (media fills) and providing guidance during execution, report reviews and approvals. /span/lilispan Validating and revalidating sterility-related test methods and aseptic processes to ensure compliance and robustness. /span/lilispan Representing the sterility assurance function in internal and external audits, addressing observations related to sterility, and driving responses and actions. /span/lilipbspan Leadership and Collaboration:/span/b/p/lilispan Support a multidisciplinary team to achieve sterility assurance objectives, providing training on aseptic and contamination control principles. /span/lilispan Support/lead monthly contamination control committee providing technical analysis regarding EM performance and system health. /span/lilispan Working cross-functionally with Quality, Quality Control, Manufacturing, Validation and Engineering teams to ensure alignment on sterility assurance requirements. /span/lilispan Acting as a key advisor to manufacturing teams, supporting investigations and CAPAs for sterility-related deviations. /span/lilispan Lead or support quality investigations, risk assessments, and CAPA development. Ensure all quality records are scientifically sound, closed on time, and aligned with regulatory expectations and internal policies. /span/lilibspan Documentation and Reporting:/span/b/lilispan Approving and maintaining documentation, including SOPs, validation protocols, contamination control plans, and trend reports. /span/lilispan Tracking and reporting contamination control performance metrics to identify areas for improvement and enhance contamination control strategies. /span/lilispan Write and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews. /span/lilispan Support inspection readiness plans and interact with regulatory agencies during inspections on contamination control related subject matter. /span/lilispan Assess Impact to CCS as the functional area owner per Change Management/span/lilipbspan GMP Qualification /span/b/p/lilispan Supporting the qualifications of isolators, and other clean air equipment. /span/lilispan Supporting the qualifications of cleanrooms including aspects such as Cleanroom Recovery, Airflow Visualization and Environmental Classification. /span/lilispan Supporting the qualification of critical utilities including Compressed Gas(s) and WFI systems. /span/li/ulp/ppb Education and Experience:/b/pullipspanspan·/span/spanspan Educational Background: Minimum of a Bachelor's degree is preferred in Microbiology, Biotechnology, or a related discipline. /span/ppspanspan·/span/spanspan Work experience: 6-10 years of sterility assurance/contamination control or GMP experience (Commercial preferred). /span/ppspanspan·/span/spanspan Regulatory Knowledge: Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits. /span/ppspanspan·/span/spanspan Aseptic Process Expertise:/span/ppspanspanospan /span/span/spanspan Proven experience in contamination control strategies/span/ppspanspanospan /span/span/spanspan Proven experience with clean air equipment, environmental monitoring, and aseptic processing simulations. /span/ppspanspan·/span/spanspan Leadership Skills: Strong ability to mentor and develop teams, lead investigations, and drive sterility assurance initiatives. /span/ppspanspan·/span/spanspan Risk Assessment amp; Problem-Solving: Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive actions. /span/ppspanspan·/span/spanspan Technical Proficiency: Proficient in the use of contamination control tools, monitoring systems, including LIMS, Excel, and project management software. /span/p/li/ulp/pp/ppspan We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:/span/ppspan1. /spanbspan Hybrid /span/bspanand work remotely up to two days per week; or select/span/ppspan2. /spanbspan On-Site/span/bspan and work 5 days per week with ad hoc /spanspanspanflexibility. /span/span/ppspan#LI-AR1 #LI-Hybrid/span/pp/pp/ppb Pay Range:/b/p$124,800 - $187,200p/ppb Disclosure Statement:/b/pdivdivdivdivp The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. /pp/pp At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. /pp/p/div/div/div/divp/ppb Flex Designation:/b/pRemote-Eligiblep/ppb Flex Eligibility Status:/b/pp In this Remote-Eligible role, you can choose to be designated as: br/1. bRemote/b: work remotely five days per week and come into the office on occasion - you're always welcome on-site; bor select/b br/2. bHybrid/b: work remotely up to two days per week; bor select/bbr/3. bOn-Site/b: work five days per week on-site with ad hoc flexibility. /ppspanspan Note: /span/spanspanspan The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. /span/spanspan /span/pp style="text-align:left"bCompany Information/b/pp style="text-align:left"span Vertex is a global biotechnology company that invests in scientific innovation. /span/pp style="text-align:inherit"/pp style="text-align:left"span Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. /span/pp style="text-align:inherit"/pp style="text-align:left"span Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at spanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspanspan class="WOY2"ApplicationAssistance@vrtx. com/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/span/p/div

Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Manager/Sr. Manager, Pre-Clinical QA provides oversight of regulated laboratory activities and ensures that quality systems are developed and maintained to regulatory and Incyte standards. This position is responsible for leading, developing, and maintaining the quality assurance programs, conducting and managing the quality assurance audit functions for Incyte Good Laboratory Practice (GLP) and Good Clinical Laboratory Practice (GCLP) regulated activities. Conducting internal and external audits to ensure all GLP/cGLP relevant regulations, guidelines, strategies and standard operating procedures (SOP) are adhered to. Perform Preclinical QA qualification and routine audits for all outsourced regulated GLP toxicology, nonclinical and clinical bioanalytical, and clinical laboratories. Generate audit agendas and reports to summarize findings. Evaluate audit responses, follow up on responses and ensure audit closure Conduct external vendor audits for clinical sample analyses to ensure compliance with GLP, GCP, and CLIA/CAP, as applicable. Ensure regulated internal bioanalytical laboratories and associated functions (toxicokinetic and pharmacokinetic) meet all GLP requirements for nonclinical and clinical study sample analyses. Conduct internal audits of regulated nonclinical and clinical bioanalytical and toxicokinetic studies including in-phase inspections, report/raw data reviews, and process/facility audits for compliance with protocols, company SOPs, and GLP regulations. Ensure business timelines are met. Summarize and/or review audit observations, responses and generate audit reports. Follow up on audit findings and report any non-compliances to functional and quality management. Use Quality Management systems for reporting and tracking QA activities. Assist with Quality Assurance initiatives and projects including document management, SOP writing and review, training, and CAPA. Provide support and guidance in interpreting the applicable GLP regulations and liaise with the business functions to resolve any quality and compliance issues on an ongoing basis for functions supporting GLP studies or clinical laboratories. Assist with development and implementation of Preclinical Quality Assurance GLP SOPs, forms, templates and attachments. Assist with GLP training program and provide training as needed to company employees. Assist with regulatory agency inspections and inspection readiness. Assist with archival of QA documents in accordance with federal regulations and ensure all data and documents associated with internal GLP activities are archived in accordance with federal regulations. Keep current on governmental regulatory requirements related to Good Laboratory Practice for Nonclinical Laboratory Studies, Title 21 CFR §58. Other duties as assigned Qualifications (Minimal acceptable level of education, work experience, and competency) Bachelor's degree required, preferably in a scientific discipline. 5-10 years' experience in Pharmaceutical or biotechnology environment. Minimum of 1-2 years' lead auditor experience performing GLP compliance audits of vendors, and/or internal systems/process/facility. Understanding of GLP regulations and experience with bioanalytical testing of small and large molecule drug substance in regulated environment is preferred. Ability to manage and prioritize projects under tight deadlines. Strong written, oral communication, interpersonal, and organization skills. Strong computer skills including knowledge and experience using Microsoft applications, Analyst, Watson, WinNonlin, and document management systems. Ability to travel 30%. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.