Vice President, Quality Control

Role: Vice President, Quality Control, overseeing global QC strategies, laboratory operations, and data integrity for viral vector and advanced therapy products in a biopharma with a focus on cancer immunotherapies. Responsibilities: lead QC systems, specifications, validation, and lifecycle management supporting clinical and commercial programs; ensure compliance with FDA, EMA, ICH, and cGMP; oversee internal and CRO/CMO labs; support manufacturing release/testing; manage investigations, deviations, and CAPA; advance digital transformation of QC processes; build and lead a high-performing team. Requirements: 15+ years in Quality Control within biopharma, with experience supporting biologics, viral vectors, or cell/gene therapies; advanced scientific degree preferred; deep knowledge of validation, microbiology, stability, and data integrity; experience with global regulatory submissions and inspections; leadership and team management skills. HighValue: biologics, viral vectors, advanced therapies, gene therapy, cGMP compliance, global regulatory engagement, clinical to commercial lifecycle. WorkSetup: hybrid (Needham, MA, 2-3 days/week); US work authorization required.