Director, QA Operations

<div class="content-intro"><p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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.</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">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.</span></p></div><p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech is seeking a <strong>Director, QA Operations</strong> as part of the <strong>Quality</strong> team based in <strong>Raritan, NJ.</strong></span></p> <p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Role Overview</span></strong></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">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.</span></p> <p><strong><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Key Responsibilities</span></strong></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Partners with other Legend functional leaders to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible for all aspects of incoming and final product disposition for the site.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible for batch record review activities for the site.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Oversees quality shop floor program to ensure compliance of the manufacturing operations.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Responsible for providing quality oversight of the QC laboratory.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manages team of senior managers and professionals within Quality. Hires and develops employees within the department.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Coordinates quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Establishes effective partnerships with other business units, sites, and individuals to ensure business processes are effectively linked.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span s