Senior Director, Product Quality Assurance, Cambridge
$260,000–$320,000 year
On-site · Cambridge, Massachusetts, United States
Job Summary
Senior Director, Product Quality Assurance leads GMP quality oversight of external manufacturing (CDMOs) and QC activities in Cambridge and globally, establishing KPI/metrics for CDMO relationships, driving continuous improvement of CDMO oversight processes, and providing leadership on cGMP compliance. The role includes approving regulatory filings, overseeing batch record review and release, leading investigations and CAPA activities, conducting GxP audits of contract service providers, and ensuring quality systems support product release and regulatory compliance across commercial and clinical products. The position requires extensive experience in biopharma/biotech quality management, CDMO oversight, GMP/qGSP knowledge, and strong cross-functional leadership to support Beam’s GMP strategy and global operations.
Required Qualifications
- Bachelor's or Advanced degree in a scientific discipline
- 15+ years’ experience in the pharmaceutical/biotech industry with drug substance/drug product manufacture, development and quality (CT/GT/biologics)
- 7+ years of Quality management experience with a successful track record in managing CDMOs and internal QA systems in a virtual environment
- Experience in auditing/vetting CDMOs
- Understanding of worldwide requirements of cGMP and quality systems for commercial and clinical products
- Excellent verbal and written communication skills, detail-oriented, and ability to drive change across functions
- Experience interacting with regulatory health authorities at pre- and post-approval inspection
- Training in GxP systems
- Ability to evaluate Quality Systems and drive value-added enhancements
- Strong team player with customer service approach
- Attention to detail and ability to work in multi-disciplinary teams and with external partners/vendors
- Excellent leadership and management skills
- Experience managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives
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