Director, Quality Assurance

Role: Director of Quality Assurance overseeing GMP QA operations for internal and external manufacturing supporting Agenus's immuno-oncology therapies. Responsibilities: manage quality systems, batch records, SOPs, vendor quality oversight, audit preparation, and regulatory inspection readiness; support clinical compliance with GCPs; lead validation, CAPA, deviation investigations, and contribute to regulatory submissions. Requirements: Bachelor's in a scientific discipline; 10+ years in biotech/pharma QA, including leadership; strong GMP, GxP knowledge; experience with biologics, cell therapy, or ATMPs preferred; proven track record with FDA, EMA inspections; experience managing CMOs, vendor qualification, validation activities; excellent communication and team leadership skills. High-Value: biologics/cell therapy, GMP, GCP, GLP, FDA/EMA compliance, inspection readiness, external vendor oversight, and supporting clinical and commercial phases. WorkSetup: onsite in Lexington, MA.