QA Operations Director

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 a Director, QA Operations as part of the Quality team based in Raritan, NJ.

Role Overview

The Director of Quality Operations, CAR-T is responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with established cGMP requirements. Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others. The role develops and implements long-term and execution of Quality programs. This role will also be responsible for trending of quality operations metrics and developing continuous improvement initiatives for the team and processes. The Director also manages a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities.

Key Responsibilities

• Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements.
• Partners with other Legend functional leaders to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.
• Responsible for all aspects of incoming and final product disposition for the site.
• Responsible for batch record review activities for the site.
• Oversees quality shop floor program to ensure compliance of the manufacturing operations.
• Responsible for providing quality oversight of the QC laboratory.