Senior Manager Quality Control Investigations
Bristol Myers Squibb•Devens, MA
•$124,590 - $150,977•Onsite
About The Position
This role provides Quality Control (QC) leadership and ownership for site investigations and CAPA execution related to QC operations and laboratory activities. The position is accountable for ensuring investigations are scientifically sound, timely, and compliant, while partnering closely with Quality Assurance for independent oversight and regulatory alignment.
Requirements
- Bachelor’s degree in Life Sciences, Biotechnology, Chemistry, Microbiology, or a related scientific discipline.
- 5–8 years of experience in Quality Control and/or GMP laboratory operations within the biotech or pharmaceutical industry.
- Demonstrated expertise leading laboratory investigations, root cause analysis, and CAPA management in a regulated environment.
- Strong working knowledge of cGMP regulations, ICH guidelines, data integrity principles, and laboratory quality systems.
Nice To Haves
- Experience with electronic quality systems (e.g., Veeva, TrackWise, SAP) and laboratory informatics (e.g., LIMS) preferred.
Responsibilities
- Lead and manage the deviation and investigation process for Quality Control operations, including analytical testing, microbiology, bioassay, environmental monitoring, and laboratory systems.
- Serve as the QC subject matter expert (SME) for root cause analysis, CAPA development, and effectiveness verification related to laboratory and testing-related events.
- Ensure investigations are data-driven, scientifically rigorous, and supported by appropriate laboratory evidence, trending, and risk assessment.
- Partner with Quality Assurance, Manufacturing, MSAT, Engineering, and Regulatory to ensure investigations meet regulatory expectations while accurately reflecting QC process and laboratory realities.
- Own monitoring and trending of QC-related investigation data to identify recurring issues, systemic risks, and opportunities for continuous improvement.
- Support internal audits and regulatory inspections by providing QC investigation expertise, documentation, and direct engagement with inspectors as needed.
- Develop, standardize, and deliver training for QC personnel on investigation best practices, data integrity, and compliance expectations.
- Drive continuous improvement initiatives within QC to strengthen investigation quality, documentation consistency, and inspection readiness.
- Ensure QC investigation activities comply with applicable global regulations (FDA, EMA, ICH) and internal quality standards.
Benefits
- Medical, pharmacy, dental, and vision care.
- BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
- Flexible time off (unlimited, with manager approval, 11 paid national holidays) for US Exempt Employees.
- 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays for Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees.
- Unlimited paid sick time.
- Up to 2 paid volunteer days per year.
- Summer hours flexibility.
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs.
- Annual Global Shutdown between Christmas and New Years Day.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
