QA Investigations Lead II

Confirmed live in the last 24 hours

Legend Biotech

Compensation

$61,454 - $80,656/year

Raritan, New Jersey, United States

Hybrid

Posted March 10, 2026

Job Description

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 QA Investigations Lead I as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Investigation Lead is an exempt level position reporting to the QA Investigation Supervisor within the Raritan Investigation Excellence Team. The QA Investigations Lead is responsible for providing quality oversight and guidance during the investigation of events that occur in the production of a personalized cell therapy product in a sterile GMP environment. The ideal candidate for this role demonstrates the quality mindset to strive for excellence, continuous improvement and ethical conduct in attaining and maintaining the highest levels of quality.

Key Responsibilities

Ensure the timely completion of high-quality robust investigations with appropriate root cause(s).
Ensure appropriate Corrective and Preventative Actions (CAPA’s) are developed and implemented.
Escalation of events to management that potentially represent significant quality issues or issues resulting in the delay of investigation closure and product release.
Support regulatory inspections and audits by ensuring inspection readiness within facility and serving as an SME during the execution of regulatory inspections and audits as needed.
Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and cGMPs.
Collaborate with site personnel to provide guidance and determine resolution for end-to-end manufacturing issues.