Senior Hybrid IT Quality & Compliance Specialist

Legend Biotech, Inc.; Bridgewater Township (NJ); Hybrid; USD 84,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

401(k) retirement plan with company 
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Paid parental leave

Paid time off and holidays

Flexible benefits

Job summary

Legend Biotech, Inc. seeks a Sr. Specialist, Quality IT in Bridgewater, NJ to provide IT Quality oversight for GxP computerized systems. You will interpret regulatory requirements, ensure data integrity, and support lifecycle management following FDA and EU guidelines.

The role collaborates with IT, Quality, and system owners to maintain compliant operations, perform risk assessments, and contribute to inspection readiness. A strong background in GxP and validation is required.

Qualifications

• 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.

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.

Skills

GxP knowledge

Regulatory compliance

Documentation

Communication

Problem solving

Risk assessment

Education

Bachelor's degree in Science/IT/Engineering

Advanced degree or professional certification preferred

Tools

QMS

Document management

Validation management

Change control

LIMS

Veeva

ERP

SAP

Job description

Legend Biotech, Inc. seeks a Sr. Specialist, Quality IT in Bridgewater, NJ to provide IT Quality oversight for GxP computerized systems. You will interpret regulatory requirements, ensure data integrity, and support lifecycle management following FDA and EU guidelines.

The role collaborates with IT, Quality, and system owners to maintain compliant operations, perform risk assessments, and contribute to inspection readiness. A strong background in GxP and validation is required.