Associate Director, GxP Compliance and Auditing
Listed on 2026-10-06
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Healthcare
Data Scientist, Medical Science -
Quality Assurance - QA/QC
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases.
From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases.
From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.
Legend Biotech is seeking an Associate Director, GxP Compliance and Auditing as part of the Global Quality team based in Bridgewater, NJ
.
The Associate Director, GxP Compliance and Auditing, serves as the strategic leader for the development,implementation, and continuous enhancement of Legend Biotech’s global GxP compliance and auditing programs. This role oversees all core elements of the compliance framework, including internal and externaaudits, inspection readiness and logistics, supplier quality management, regulatory intelligence monitoring and dissemination, Quality Management Review oversight, and quality planning activities. Based in Bridgewater, this people-manager position oversees one direct report and is responsible for conducting internal audits at the Somerset and Raritan CARVYKTI sites, performing external third-party and supplier audits, and routinely supporting inspection readiness and related compliance activities across the Somerset and Raritan manufacturing facilities with on-site travel expected.
Key Responsibilities- Lead and own global GxP compliance and auditing programs.
- Serve as the Global Business Process and System Owner for Compliance and Auditing.
- Define, implement, and maintain compliance processes, procedures, tools, and training for internal and external auditing, inspection readiness, Quality Management Review, emerging regulations, regulatory trends, and quality planning.
- Develop, implement, and continuously improve compliance processes and systems.
- Identify, implement, and maintain IT solutions that support compliance and auditing programs.
- Interpret and apply global…
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