Associate Manager, Quality Assurance Operations

Role: Associate Manager, Quality Assurance Operations, overseeing external manufacturing compliance in cell/gene therapy biopharma. Responsibilities: provide QA support for GMP manufacturing, manage deviations, change controls, and audits; serve as QA liaison with CMOs; monitor quality metrics, review validation and product quality reports, and oversee quality agreements. Requirements: Bachelor’s in Life Sciences or Engineering; 4-6 years in QA within GMP biopharma, with strong knowledge of cGMP regulations, deviations, CAPA, and validation processes; experience supporting CMO oversight and manufacturing environments. Preferred: knowledge of lentiviral vector processes and biologics. High-Value: focus on cell/gene therapy, GMP manufacturing, CMO management, deviation and change control, validation, and quality system oversight. Work setup: hybrid (3 days/week in Somerville, MA), occasional travel, on-call QA support.