Associate Director, Quality Systems

Role: Associate Director, Quality Systems at a cell therapy manufacturing site, overseeing quality systems operations supporting GMP compliant CAR-T production in Raritan, NJ. Responsibilities include managing teams responsible for document control, investigations, CAPA, change control, and site quality metrics; ensuring inspection readiness; leading risk management initiatives; and supporting regulatory audits. The role involves cross-functional collaboration with Manufacturing, QC, Engineering, and other stakeholders to optimize quality processes and compliance. Requirements: Bachelor's in Science, Engineering, Biotechnology, or related field; minimum 10 years of quality experience in cGMP biotech or cell/gene therapy manufacturing, with sterile environment expertise preferred. Skills include leadership of quality systems, investigations, CAPA, regulatory inspection readiness, and risk management. High-value specifics: focus on cell therapy (CAR-T), GMP sterile manufacturing, quality systems oversight, investigations, and compliance within a regulated biotech environment. Location: Raritan, NJ; work setup not specified but implies on-site involvement.