Sr. Specialist, Quality IT

The posting, as Legend Biotech US wrote it

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.
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t- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay)

$110,706 — $145,303 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice .