QA Investigations Supervisor

Overview

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 platforms including autologous and allogeneic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell–based immunotherapies. From our three R&D sites worldwide, we pursue safe, efficacious, and cutting-edge therapeutics for patients.

Legend Biotech is seeking a QA Investigations Supervisor as part of the Quality team based in Raritan, NJ
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The QA Investigation Supervisor will be 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 and support, and continuous improvement projects within the Raritan Investigations organization. The role requires an exceptionally organized, logical professional with experience to enhance the quality of investigations, ensure compliance with applicable procedures, and strengthen CAPA plans for greater accuracy, effectiveness, and compliance.

• Supervise QA Investigation Leads: Lead daily touch point meetings with direct reports and monitor QA Investigation Lead workload. Provide guidance on investigation performance, process knowledge of cell and gene therapy manufacturing, and compliance to ensure high-quality investigations.
• Investigation Support: Ensure investigations comply with applicable regulatory requirements; escalate events representing significant quality issues or potential delays in investigation closure or product release; support review of investigation-related documents (SOPs, Work Instructions, Job Aides); help QA Leads resolve roadblocks to ensure compliant closures in support of batch release and site timelines.
• Investigation Metrics Ownership: Own and monitor investigation metrics and implement actions when trends are negative or criteria are not met.
• Internal/External Audit Readiness/Support: Serve as SME in preparation for and during audits (e.g., FDA, EMEA); ensure audit readiness of the Raritan investigations team; coach quality leads and prepare records for audits/inspections.
• Continuous Improvement Project Support: Represent quality on project improvement teams; ensure process improvements incorporate quality risk management principles and update reference documents supporting investigations.

• 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 biotech/biopharma environment;
  Cell/Gene Therapy cGMP manufacturing experience preferred.
• A minimum of 2 years of experience managing a team.
• Significant experience with training and quality tracking systems.
• Demonstrated experience leading complex multi-disciplinary investigations in a cGMP environment.
• Experience partnering with leadership across complex organizations; ability to build strong partnerships with internal and external stakeholders in a matrixed environment.
• Excellent organizational and project management skills; ability to simplify and clearly communicate complex concepts.
• Strong analytical, problem-solving, and decision-making skills; excellent verbal, written, and presentation capabilities.
• Energetic and collaborative; proficient in data collection and analysis; ability to guide others in analytical thinking and skill development.

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles.

The anticipated base pay range is: $93,463 USD - $122,670 USD

Benefits include medical, dental, and vision insurance, a 401(k) plan with a company match that vests on day one, eight weeks of paid parental leave after three months, and…