Senior Manager, Quality Assurance - Lab Operations

Bristol Myers Squibb-posted 27 days ago
Full-time • Manager
Devens, MA
5,001-10,000 employees
Chemical Manufacturing
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The Senior Manager, Quality Assurance - Lab Operations is responsible for leading QA oversight of laboratory operations supporting GMP testing, method validation, and stability programs in a biotechnology manufacturing environment. This role ensures that all laboratory activities are conducted in compliance with applicable regulations, internal procedures, and industry best practices. The position plays a key role in maintaining data integrity, supporting regulatory inspections, and driving continuous improvement across quality control laboratories.

  • Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies.
  • Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data.
  • Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations.
  • Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions.
  • Manage and mentor a team of QA professionals supporting lab operations.
  • Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents.
  • Participate in internal audits and regulatory inspections as a QA representative and subject matter expert.
  • Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture.
  • Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare).
  • Strong leadership, communication, and interpersonal skills.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Experience supporting regulatory inspections (FDA, EMA, etc.).
  • Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field.
  • 8+ years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment.
  • 3+ years of leadership or management experience.
  • Strong understanding of analytical testing, method validation, and stability programs for biologics.
  • In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles.
  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
  • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
  • Other perks like tuition reimbursement and a recognition program.
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