Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Sr. Specialist, Quality IT as part of the Quality IT team based in Bridgewater, NJ.

Role Overview

The Sr Specialist, IT Quality provides IT Quality oversight and hands-on support for the implementation, validation, operation, and lifecycle management of GxP computerized systems within Legend Biotech. The role interprets applicable regulatory requirements, applies IT Quality Assurance standards, and supports compliant processes and documentation. The position helps ensure that GxP electronic systems and records comply with company procedures and applicable requirements for electronic records, electronic signatures, data integrity, cGMP, GCP, GLP, FDA 21 CFR Parts 210, 211 and 11, EU Annex 11, and GAMP 5 guidance.

Key Responsibilities

Ensure assigned GxP IT systems, processes, and records comply with Legend CSV/CSA and SDLC procedures and applicable regulatory requirements.
Provide IT Quality review and oversight for GxP system implementations, enhancements, upgrades, validation activities, and associated change controls.
Review validation and lifecycle documents, including validation plans, system risk assessments, user requirements, test protocols and reports, traceability matrices, release documentation, and retirement records.
Partner with IT, business, Validation, Quality, and system owners to support system maintenance, upgrades, issue resolution, and compliant operation.
Support the development, revision, and implementation of SOPs, work instructions, templates, and standards governing GxP computerized systems.
Assess and document risks associated with GxP computerized systems and processes and support implementation of appropriate risk controls.
Support investigations of system or application issues, deviations, data-integrity concerns, and recurring error trends; contribute to root-cause analysis and corrective and preventive actions.
Track assigned audit observations, deviations, CAPAs, and remediation actions to timely completion in accordance with internal procedures.
Support the IT supplier qualification and annual supplier audit program, including assessment documentation, audit preparation, follow-up, and record maintenance.
Provide Quality oversight for system periodic reviews, access reviews, backup and recovery evidence, security and audit-trail reviews, and other lifecycle controls, as applicable.
Support inspection readiness and participate in internal audits, supplier audits, and regulatory inspections by retrieving records, explaining controls, and coordinating responses.
Monitor relevant regulatory and industry developments and help translate new expectations into practical improvements to procedures and controls.
Provide guidance and training to IT personnel and key stakeholders on GxP, data integrity, CSV/CSA, electronic records and signatures, and internal Quality requirements.
Support continuous improvement through process metrics, trend analysis, lessons learned, and risk-based simplification of validation and Quality processes.