Sr. Specialist, Quality IT

Legend Biotech US; Bridgewater Township (NJ); Hybrid; USD 110,000 - 170,000; Full time

Job summary

Legend Biotech US seeks a Sr. Specialist, Quality IT in Bridgewater, NJ to oversee GxP IT systems, validate lifecycle activities, and ensure data integrity and compliance across CSV/CSA frameworks.

You will partner with IT, Validation, Quality, and system owners to drive risk-based controls, support regulatory inspections, and train teams on GxP and electronic records requirements.

Qualifications

• 7+ years in pharma/biotech or medical devices with 4+ years QA/CSV/regulatory lifecycle activity.
• Experience with FDA 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
• Able to review and author validation/lifecycle deliverables and risk assessments.
• Experience with regulated platforms (QMS, LIMS, ERP, SAP, Veeva) and change controls.

Responsibilities

• Provide IT Quality oversight for GxP system implementations, validations, and lifecycle activities.
• Review validation plans, test protocols, traceability matrices, and reports.
• Collaborate with IT, business, and QA to maintain compliant operations and documentation.
• Support risk assessments, CAPAs, deviations, and supplier audits as needed.
• Assist in inspections readiness and respond to regulatory inquiries with records.
• Train IT personnel on GxP, CSV/CSA, data integrity, and electronic signatures.

Skills

Technical writing

Documentation review

Analytical thinking

Problem solving

Communication

Collaboration

Prioritization

Education

Bachelor's in Science/IT/Engineering

Advanced degree preferred

Tools

QMS

Document Management

Validation Management

Change Control

LIMS

Veeva

ERP

SAP

Job description

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.
• Manage multiple assignments with limited day‑to‑day direction, elevate significant compliance risks promptly, and seek management guidance for complex or precedent‑setting decisions.
• IT leadership and delivery teams; Quality Assurance and Validation; system and business process owners; project management; Information Security; Data Integrity; internal audit and inspection‑readiness teams; and external software, service, and consulting suppliers.

Requirements

• Bachelor’s degree in Science, Information Technology, Engineering, or an equivalent technical discipline.
• An advanced degree or relevant professional certification is preferred.
• A minimum of 7 years of relevant experience in the pharmaceutical, biotechnology, or medical‑device industry, including at least 4 years supporting Quality Assurance, computerized system validation/assurance, IT Quality, or regulated computerized‑system lifecycle activities.
• Working knowledge of global GxP requirements and expectations for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5.
• Experience reviewing or authoring validation and lifecycle deliverables such as risk assessments, requirements, test protocols, traceability matrices, validation reports, change controls, deviations, and CAPAs.
• Experience with one or more enterprise or regulated platforms, such as QMS, document management, validation management, change control, LIMS, Veeva, ERP, or SAP.
• Ability to apply risk‑based CSV/CSA principles and translate compliance requirements into practical actions.
• Strong technical writing, documentation‑review, analytical, and problem‑solving skills.
• Ability to communicate clearly and collaborate effectively with internal stakeholders and external suppliers.
• Ability to prioritize and manage multiple concurrent assignments while maintaining documentation quality and meeting commitments.
• Highly motivated, adaptable, organized, detail‑oriented, and capable of working with limited day‑to‑day supervision.
• Experience supporting audits or regulatory inspections is preferred.
• Experience with clinical systems is preferred.

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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance‑based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a