Director, QA Operations

Role: Director, QA Operations for CAR-T manufacturing, overseeing quality assurance activities for cell therapy production in compliance with cGMP standards. Responsibilities include managing daily quality operations, disposition of incoming materials and final drug products, batch record review, shop floor oversight, and QC laboratory quality. The role also focuses on continuous process improvement, trending quality metrics, and developing quality programs. The director manages a team of senior managers and technical professionals, fostering talent development and ensuring cross-functional collaboration across manufacturing and quality units. Requirements: Bachelor's in Science or related field; minimum 14 years' experience in quality assurance within aseptic, cell therapy, or biologics manufacturing; strong knowledge of cGMP, FDA/EU regulations, and Good Tissue Practices; proven leadership skills; experience with quality systems, microbiology, and aseptic processing in ISO 5 clean rooms preferred. High-value specifics include expertise in cell therapy, CAR-T processes, and compliance with regulated manufacturing environments. The position is based in Raritan, NJ, with responsibilities encompassing vendor and site-wide quality oversight.