Senior Manager Quality Control Investigations

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 with Quality Assurance for oversight and regulatory alignment. Responsibilities Lead and manage QC deviation and investigation processes (analytical testing, microbiology, bioassay, environmental monitoring, lab systems). Act as QC SME for root cause analysis, CAPA development, and effectiveness verification. 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. Own monitoring and trending of QC investigation data to identify recurring issues and improvement opportunities. Support internal audits and regulatory inspections with documentation and inspector engagement. Develop and deliver QC training on investigation best practices, data integrity, and compliance. Drive continuous improvement to strengthen investigation quality and inspection readiness. Ensure QC investigation activities comply with FDA/EMA/ICH and internal standards. Qualifications Bachelor’s degree in Life Sciences/Biotech/Chemistry/Microbiology or related field. 5–8 years QC and/or GMP laboratory operations in biotech/pharma. Experience leading lab investigations, root cause analysis, and CAPA management in regulated environments. cGMP, ICH, data integrity, and laboratory quality systems knowledge. Preferred: experience with electronic quality systems (Veeva, TrackWise, SAP) and LIMS/informatics. Compensation / Benefits (if eligible) Devens, MA: US $124,590–$150,977 (FTE). Additional incentive cash/stock may be available. Health, wellbeing, financial protection (e.g., 401(k), disability, life insurance) and paid time off. Application instructions If the role doesn’t perfectly match your resume, you are encouraged to apply anyway. #J-18808-Ljbffr