legendcareers · Bridgewater, New Jersey, United States · Bridgewater, New Jersey, United States
<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> Sr Manager, Quality IT</strong> as part of the <strong>Quality IT</strong> team based in <strong>Bridgewater, NJ.</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Role Overview</strong></span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The Sr Manager, Quality IT is responsible for providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech. Duties include, but are not limited to interpreting applicable regulations, defining IT QA requirements and implementing processes and procedures at Legend that comply with regulatory guidelines and company standards. This position will ensure that GxP electronic systems adhere to both national and international regulatory guidelines on Electronic Records, Electronic Signatures, Data Integrity, cGMP, GCP, GLP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines</span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Key Responsibilities</strong></span></p> <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensure that GxP IT systems, processes and records adhere to Legend CSV and SDLC procedures, FDA, EMEA and other regulatory 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;">Provide IT Quality oversight for GxP System enhancement and validation activities inclusive of documentation and change controls. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Contribute to the development and enforcement of applicable standard operating procedures at Legend. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Work with cross-functional teams for System upgrades, maintenance, and recommendations for purchasing software, working with the relevant departments to develop user requirements and ensuring regulatory compliance. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Assist in the development and coordination of Software Validation Plans; Installation, Operational and Performance Qualification protocols and reports; System Risk Assessments, Standard Operating Procedures; and Requirements Traceability Matrices. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintain master files, profiles and tables for multiple software applications and drive harmonization across 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;">Review and approve IT systems change management documentation, authorizing system use upon verification that requirements are met. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Monitor error reports and assure data integrity. Investigate and document application problems and recommend system and/or procedural changes. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support and maintain the annual IT supplier audit program. </span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ensure audit observations, deviations, CAPAs are communicated, tracked, and remediated, in compliance with internal policies and procedures a