Senior Manager, Quality Assurance - Lab Operations

Senior Manager, Quality Assurance - Lab Operations

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Position Summary 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.

Key Responsibilities

• 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.

Qualifications & Experience

• 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.).
• Bachelors or Masters 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.

The starting compensation for this job is a range from US-MA- $ 130,020-$157,600 plus incentive cash and stock opportunities (based on eligibility).