CQV Supervisor

Role: CQV Supervisor supporting cGMP clinical and commercial cell therapy manufacturing at Legend Biotech. Primary objectives include leading commissioning, qualification, validation, and maintenance activities for facility, equipment, and systems, ensuring compliance with cGMP and regulatory standards. Responsibilities encompass managing complex CQV projects, executing protocols and reports, supporting deviations and CAPAs, and representing CQV in internal and regulatory audits. Requirements: Bachelor's in Science, Engineering, or related field; at least 7 years of relevant experience, preferably in aseptic or cell therapy manufacturing, with strong knowledge of cGMP regulations, FDA/EU guidance, and documentation practices. Preferred skills include familiarity with ERP systems (Maximo, Siemens EMS), testing tools (Kaye AVS), and experience with ICH and CFR parts applicable to cell therapy. The role involves cross-functional collaboration within a fast-paced, validated manufacturing environment, with oversight of technical investigations and change controls. The position is based in Raritan, NJ, with responsibilities for maintaining robust CQV programs to support personalized cell therapy production, testing, and product release.