Sr. CQV Specialist

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, the company develops 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 its R&D sites worldwide, Legend applies these innovative technologies to pursue safe, efficacious, cutting‑edge therapeutics for patients. The role is based in Raritan, NJ and requires a Sr. CQV Specialist within the Technical Operations team. Role Overview This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. The individual will handle day‑to‑day activities, including execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts for facilities, equipment, systems and processes to support safe and compliant production of personalized cell therapy products according to cGMP requirements. Key Responsibilities Executes the commissioning, qualification, re‑qualification, validation and any associated maintenance activities within the plant. Manages multiple and complex CQV projects, collaborating with cross‑functional teams, providing status reports and coordinating with other departments or outside contractors/vendors to complete tasks. Supports and/or owns technical and quality investigations, CAPAs and corrections. Develops and performs remediation efforts and associated CAPA plans. 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. Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation. Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans and Annual Product Reviews. Provides training and support to junior team members on CQV activities. Prepares and presents CQV work to regulatory and internal audit teams. Other responsibilities as assigned. Decides on corrective action for deviation events. Determines technical approach and methodology per applicable procedure. Requires manager approval for resource assignment, timeline shifts, strategic shifts and finance‑related events. Requirements A minimum of a Bachelor’s Degree in Science, Engineering or an equivalent technical discipline. A minimum of 7 years of relevant work experience, preferably in an aseptic manufacturing facility, cell therapy, testing facility, quality assurance or manufacturing compliance. Experience with Microsoft suite and ERP systems such as Maximo, Siemens EMS, Comet, Kneat, and testing systems such as Kaye AVS and Kaye Valprobe. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products, and Good Tissue Practices. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and make critical decisions with limited information. Proficiency in applying process excellence tools and methodologies. Ability to independently manage a portfolio of ongoing projects. Attention to detail and adherence to procedures. High organization and capability to work in a team environment with a positive attitude. Experience summarizing and presenting results and collaborating in teams. In‑depth knowledge of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR‑T manufacturing or cell processing. Ability to identify and remediate gaps in processes or systems. Experience with ICH and/or 21 CFR parts 210, 211, 1271; knowledge of parts 600, 601 and 610 is preferred. Experience authoring and executing documentation including batch records, SOPs, work instructions and CQV protocols. Compensation and Benefits Base pay range: $110,706—$145,303 USD. Other types of pay: Performance‑based bonus and/or equity may be available to employees in eligible roles. Benefits and paid time off: Medical, dental and vision insurance, a 401(k) retirement plan with company match that vests fully on day one, eight weeks of paid parental leave after three months of employment, paid time off for vacation, personal, sick time and floating holidays, and eleven company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental plans such as pet, critical illness, accident and hospital indemnity insurance, voluntary commuter benefits, family planning and care resources, well‑being initiatives and peer‑to‑peer recognition programs. These benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits. EEO Statement Legend Biotech provides equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, genetic information or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. For information related to our privacy notice, please review: Legend Biotech Privacy Notice. #J-18808-Ljbffr Merck & Co. Inc