Associate Manager, Quality Assurance Operations

Role: Associate Manager, Quality Assurance Operations, overseeing external manufacturing quality compliance for cell/gene therapy biopharma products. Responsibilities: provide QA support for manufacturing, lead oversight of CMOs, review deviations, change controls, and validation protocols; serve as QA point for product complaints; monitor quality metrics and drive continuous improvement; manage Quality Agreements and author Annual Product Quality Reviews. Requirements: Bachelor’s in Life Sciences or related field; 4-6 years QA experience in GMP biopharma or cell/gene therapy manufacturing; strong knowledge of cGMP regulations, deviation management, and validation; experience with CMO oversight; familiarity with lentiviral vectors and biologics preferred. Key biopharma specifics: focus on cell/gene therapy, cGMP compliance, external manufacturing oversight, validation, and risk management. Collaboration: cross-functional engagement with manufacturing, MS&T, QC, and external partners. Work setup: hybrid (3 days/week in Somerville, MA); on-call support; occasional travel.