Associate Director, Quality IT

Confirmed live in the last 24 hours

Legend Biotech

Somerset, New Jersey, United States

Hybrid

Posted March 27, 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 an Associate Director, Quality IT as part of the Compliance team based in Somerset, NJ.

Role Overview

The Associate Director, Quality IT is responsible for leading the IT Quality team and providing IT Quality oversight for the implementation and lifecycle management of GxP IT systems within Legend Biotech. Duties include, but are not limited to interpreting applicable regulations, defining IT QA requirements and implementing processes and procedures at Legend that comply with regulatory guidelines and company standards. This position will ensure that GxP electronic systems(eSystems) adhere to both national and international regulatory guidelines on Electronic Records, Electronic Signatures, Data Integrity, cGMP, GCP, GLP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.

Key Responsibilities

Ensure that GxP IT systems, processes and records adhere to Legend CSV and SDLC procedures, FDA, EMEA and other regulatory requirements.
Provide IT Quality oversight for GxP eSystem enhancement and validation activities inclusive of documentation and change controls.
Direct and manage the IT Quality Team activities in accordance with compliance and business priorities.
Contribute to the development and enforcement of applicable standard operating procedures at Legend.
Work with cross functional teams for eSystem upgrades, maintenance, and recommendations for purchasing software, working with the relevant departments to develop user requirements and ensuring regulatory compliance.
Assist in the development and coordination of Software Validation Plans; Installation, Operational and Performance Qualification protocols and repo