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, escalate 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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