QA Laboratory Compliance Specialist III

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, part of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our partnership combines the strengths and expertise of both companies to advance the promise of an immunotherapy for multiple myeloma.

QA Laboratory Compliance Specialist III –
Location: Raritan, NJ

The QA Lab Compliance (QALC) Specialist III is an exempt level position responsible for quality and compliance oversight over all functions of the Quality Control Laboratories testing advanced therapy products. The specialist works collaboratively with QC departments including QC Release, QC IPL, QC Micro, QC Lab Services, and QC Investigations.

• Work in close collaboration with QC functional areas to provide QA oversight.
• Attend one‑on‑one meetings with QA supervisors.
• Train and coach Level I/II QALC on day‑to‑day activities.
• Oversee QC laboratories to ensure quality, compliance, and adherence to global standards and regulatory requirements.
• Support Level I/II QALC by overseeing spot‑check completion for QC laboratories, ensuring compliance with written regulations, policies, procedures, and global procedures.
• Provide compliance oversight of all QC operations.
• Assist the supervisor in managing cross‑functional projects with QC functional area owners.
• Perform ad‑hoc walk‑throughs of QC labs to ensure GMP is followed.
• Conduct form‑book reviews, UARs, SOP reviews, quarterly trend reports, and spot checks.
• Collaborate with QA supervisor and QC functional areas to address trends identified during spot checks and walk‑throughs.
• Strive to reduce non‑conformances by proactively driving compliance.
• Interpret complex situations independently and articulate recommendations for QA management.
• Serve as a subject matter expert on QA topics within the group to support QC lab activities.
• Support regulatory inspections and audits by ensuring QC functional areas are audit‑ready.

• Collaborate and provide QA insight to develop strategic approaches to complex investigations with cross‑functional teams.
• Guide QC in interpreting quality issues.
• Monitor investigation lifecycle to ensure timely approval.
• Ensure corrections, CAPA actions, and root‑cause actions are in place and supported.
• Collaborate with QC Investigations team to meet record closure timelines.
• Attend daily check‑in meetings to provide status updates.
• Maintain updated metrics spreadsheet.
• Escalate significant non‑conformances to management in a timely manner.
• Attend escalation meetings and support drafting minutes.
• Guide QC functional areas on non‑conformance interpretation and participate in remediation and continuous improvement.
• Provide oversight for checkpoint and rapid response calls for prompt initiation of quality issues.
• Participate in QALC weekly meetings and share investigation learnings and best practices.
• Support regulatory inspections by presenting in the front room for investigation requests.
• Collaborate with QC Release, QC IPL, QC Micro, QC Lab Services, and QC Investigations.

• Bachelor’s Degree in Science or equivalent technical discipline.
• A minimum of 2 years relevant work experience, preferably in an aseptic manufacturing facility and in quality assurance, quality control, manufacturing compliance, clinical quality, or cell therapy.
• At least 1 year of QA experience.
• Strong knowledge of nonconformance and CAPA management processes.
• Knowledge of cGMP/cGLP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals, including experience with cell‑based…