Director of Global Quality Assurance Validation

<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 RD 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><div class="col-xs-12 no-horiz-padding"><hr> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Legend Biotech is seeking a <strong>Director of Global Quality Assurance Validation </strong>as part of the <strong>Quality </strong>team based in <strong>Somerset, NJ. </strong></span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Role Overview</strong></span></p> <p class="drawer-body-p"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The Director of Quality Assurance Validation role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for facility, equipment, systems, and processes within a cell therapy manufacturing plants to support both clinical and commercial requirements in a sterile GMP environment. This role will have oversight in the US and advise for EU for Quality Assurance Validation and will manage a team of people leaders and technical professionals within the QA department based on assigned work, direction, coaching and developing capabilities. This role will collaborate with cross-functional counterparts and manage QAV for Legend commercial and clinical sites.</span></p> <p><span style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><strong>Key Responsibilities</strong></span></p> <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manage team providing quality and compliance oversight for the qualification, validation, process and equipment and facilities maintenance activities within the manufacturing and testing plant.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Ability to manage multiple and complex validation projects, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide insight and develop sound strategical approaches to complex investigations and associated CAPAs</span></li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Provide leadership and build an exceptional team to manage the Quality Assurance Validation across multiple sites, including hiring, mentoring and developing personnel.</span></li> <li style="font-size: 12pt; ... (truncated, view full listing at source)