CQV Supervisor

<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> CQV Supervisor </strong>as part of the<strong> <span class="collapsed-field-text">Facilities & Engineering</span> </strong>team based in<strong> Raritan, 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;">This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant.  This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.  This role will require CQV experience, represent CQV work in the regulator and internal audits, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program to enable robust production, testing and release of product to patients.  </span></p> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><strong>Major 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;">Executes the commissioning, qualification, requalification, validation and any associated maintenance activities within the plant.</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 multiple and complex CQV projects, collaboration with cross functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Supports and/or owns technical and quality investigations, CAPAs and corrections.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Develops and performs any required remediation efforts and associated CAPA plans.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Authors, owns and executes master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable. acceptance criteria, specifically data integrity.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Train and support the junior team members on different CQV activities.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Present CQV work to regulatory and internal audit teams.</span></li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;"> <p><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Making decision on co