Senior Manager Quality Control Investigations
Bristol Myers Squibb
8 hours ago
On-site
Devens, MA
Operations
Position Summary
Provide Quality Control (QC) leadership and ownership for site investigations and CAPA execution related to QC operations and laboratory activities. Ensure investigations are scientifically sound, timely, and compliant, partnering closely with Quality Assurance for independent oversight and regulatory alignment.
Duties / Responsibilities
- Lead and manage the deviation and investigation process for QC operations (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/testing events.
- Ensure investigations are data-driven, scientifically rigorous, and supported by laboratory evidence, trending, and risk assessment.
- Partner with Quality Assurance, Manufacturing, MSAT, Engineering, and Regulatory to meet regulatory expectations and reflect QC process/laboratory realities.
- Own monitoring and trending of QC-related investigation data to identify recurring issues, systemic risks, and continuous improvement opportunities.
- Support internal audits and regulatory inspections with QC investigation expertise and documentation.
- Develop, standardize, and deliver training for QC personnel on investigation best practices, data integrity, and compliance expectations.
- Drive continuous improvement 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.
Qualifications (Required)
- Bachelor’s degree in Life Sciences, Biotechnology, Chemistry, Microbiology, or related scientific discipline.
- 5–8 years of experience in Quality Control and/or GMP laboratory operations in 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.
Qualifications (Preferred)
- Experience with electronic quality systems (e.g., Veeva, TrackWise, SAP) and laboratory informatics (e.g., LIMS).
Application instructions
- If you see a role that intrigues you but doesn’t perfectly match your resume, apply anyway.
Provide Quality Control (QC) leadership and ownership for site investigations and CAPA execution related to QC operations and laboratory activities. Ensure investigations are scientifically sound, timely, and compliant, partnering closely with Quality Assurance for independent oversight and regulatory alignment.
Duties / Responsibilities
- Lead and manage the deviation and investigation process for QC operations (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/testing events.
- Ensure investigations are data-driven, scientifically rigorous, and supported by laboratory evidence, trending, and risk assessment.
- Partner with Quality Assurance, Manufacturing, MSAT, Engineering, and Regulatory to meet regulatory expectations and reflect QC process/laboratory realities.
- Own monitoring and trending of QC-related investigation data to identify recurring issues, systemic risks, and continuous improvement opportunities.
- Support internal audits and regulatory inspections with QC investigation expertise and documentation.
- Develop, standardize, and deliver training for QC personnel on investigation best practices, data integrity, and compliance expectations.
- Drive continuous improvement 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.
Qualifications (Required)
- Bachelor’s degree in Life Sciences, Biotechnology, Chemistry, Microbiology, or related scientific discipline.
- 5–8 years of experience in Quality Control and/or GMP laboratory operations in 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.
Qualifications (Preferred)
- Experience with electronic quality systems (e.g., Veeva, TrackWise, SAP) and laboratory informatics (e.g., LIMS).
Application instructions
- If you see a role that intrigues you but doesn’t perfectly match your resume, apply anyway.