QA Investigations Lead III

Confirmed live in the last 24 hours

Legend Biotech

Compensation

$81,273 - $106,669/year

Raritan, New Jersey, United States

On-site

Posted March 3, 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 III as part of the Quality team based in Raritan, NJ.

Role Overview

The QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This includes supporting and approving manufacturing investigations, ownership of various department projects, and tracking of quality metrics while ensuring high quality and complaint product supply.

Key Responsibilities

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 manufacturing issues.
Ensure accurate and timely maintenance and review of manufacturing investigations, CAPAs, change controls and complaints.
Review and approve manufacturing procedures.
Support regulatory inspections and audits by ensuring inspection readiness within facility.
Perform internal housekeeping audits.
Perform analysis on quality indicating data and identifying trends.
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