QA Change Control Specialist II

<div class="content-intro"><p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.</span></p> <p style="line-height: 1.2;"> </p> <p style="line-height: 1.2;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.</span></p> <p style="line-height: 1.2;"> </p></div><p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking a <strong>QA Change Control Specialist II </strong>as part of the <strong>Quality </strong>team based in <strong>Raritan, NJ.</strong></span></p> <p> </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 QA Change Control Specialist II role is an exempt level position with responsibilities for providing quality oversight over the change control process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will be responsible for managing change control activities throughout the lifecycle.</span></p> <p> </p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><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;">Support and streamline the site change control process.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Participate in change control process from initiation through completion.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Schedule and participate in the site change control review board meetings.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manage change control metrics reporting.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Collaborate with functional departments to resolve issues.</sp ... (truncated, view full listing at source)