QA Investigations Supervisor

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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, a pharmaceutical company of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

The QA Investigation Supervisor will be a part of the Raritan Investigation Excellence Team. This individual will guide a team of QA Investigation Leads in support of NC/CAPA investigation execution, internal/external audit readiness/support, and continuous improvement projects within the Raritan Investigations organization. The supervisor is an exceptionally organized, logical professional with the experience necessary to enhance the quality of our investigations, ensure compliance with applicable procedures, and elevate the robustness of our Corrective and Preventive Action (CAPA) plans.

• Supervise QA Investigation Leads:
  • Lead daily touch‑point meetings with direct reports and monitor QA Investigation Lead workload.
  • Provide guidance to quality leads in investigation performance, process knowledge of cell and gene therapy manufacturing, and compliance to ensure investigations reviewed by the team adhere to a high standard of excellence.
• Investigation Support:
  • Ensure investigation processes are compliant with all applicable regulatory requirements.
  • Escalate events that potentially represent significant quality issues or delay investigation closure and product release to management.
  • Support review of investigation execution related documents (SOPs, Work Instructions, Job Aides).
  • Assist QLs in resolving roadblocks to ensure compliant closures in support of batch release and site timeliness goals.
• Investigation Metrics Ownership:
  • Own and monitor investigation metrics, implementing actions when metrics indicate a negative trend or failure to meet accepted criteria.
• Internal/External Audit Readiness/Support:
  • Serve as subject‑matter expert in preparation for and during internal and external audits, including FDA, EMEA, etc.
  • Ensure a high level of competency and audit/inspection readiness of the overall Raritan investigation team, coaching quality leads and preparing them and quality records for audits/inspections.
• Continuous Improvement Project Support:
  • Represent quality on the project improvement team, ensuring process improvements are implemented incorporating quality risk management principles and that current reference documents supporting investigations are updated appropriately.

• A minimum of a bachelor’s degree in science or related field, or equivalent experience. Advanced degree preferred.
• A minimum of 5 years of Quality Assurance experience within a cGMP environment in the biotech/biopharma industry;
  Cell/Gene Therapy cGMP manufacturing experience preferred.
• A minimum of 2 years of experience managing a team.
• Significant experience utilizing training and quality tracking systems.
• Demonstrated experience handling/leading complex multi‑disciplinary investigations in a cGMP environment.
• Experience partnering with various levels of leadership across complex organizations.
• Ability to build strong partnerships and effectively integrate with internal and external partners to drive projects/programs forward in a matrixed environment.
• Excellent organizational and project‑management skills with the ability to simplify and clearly communicate complex concepts.
• Strong analytical, problem‑solving, and decision‑making skills.
• Excellent verbal, written, and presentation…