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, 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.

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.

Legend Biotech is seeking a Sr. CQV Specialist as part of the Technical Operations team based in Raritan, NJ
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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 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 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 that enables robust production, testing and release of product to patients.

• Executes the commissioning, qualification, re‑qualification, validation and any associated maintenance activities within the plant.
• Manages multiple and complex CQV projects, collaborates with cross‑functional teams, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
• Supports and/or owns technical and quality investigations, CAPAs and corrections.
• Develops and performs any required 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.
• Trains and supports junior team members on different CQV activities.
• Presents CQV work to regulatory and internal audit teams.
• Other responsibilities as assigned.
• Makes decisions on corrective action in deviation events.
• Decides on technical approach and methodology per applicable procedure.
• Manager approval required for resource assignment, timeline shift, strategic shift and finance related events.

• A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
• A minimum of 7 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance or manufacturing compliance.
• Ability to use following or similar systems for business needs:
  Microsoft suite & ERP systems:
  Maximo, Siemens EMS, Comet, Kneat & Testing system:
  Kaye AVS, Kaye Valprobe.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products as well as knowledge of Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to quickly process complex information and often make critical decisions with limited…