Senior IT Quality Specialist – GxP Compliance

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

Legend Biotech is seeking a Sr. Specialist, Quality IT to provide IT Quality oversight for GxP systems and lifecycle management. Based in Bridgewater, NJ, the role focuses on regulatory compliance, documentation, and cross‑functional collaboration with IT, Validation, and Quality teams.

The candidate will review validation artifacts, support SOP development, manage risk controls, and participate in inspections. Strong writing, analytical, and communication skills are essential.

Qualifications

• Bachelor's degree in Science, Information Technology, Engineering, or equivalent.
• Advanced degree or relevant certification preferred.

Responsibilities

• Provide IT Quality oversight for GxP systems and SDLC
• Review validation and lifecycle documents (plans, risk assessments, URs, test protocols, reports)
• Support SOPs, templates, and standards for GxP systems
• Assist with risk assessments and CAPAs; support audits and regulatory inspections

Skills

Technical writing

Analytical thinking

Communication

Problem solving

Education

Bachelor's degree in Science/IT/Engineering

Advanced degree or certification preferred

Tools

QMS

Veeva

ERP

SAP

Job description

Legend Biotech is seeking a Sr. Specialist, Quality IT to provide IT Quality oversight for GxP systems and lifecycle management. Based in Bridgewater, NJ, the role focuses on regulatory compliance, documentation, and cross‑functional collaboration with IT, Validation, and Quality teams.

The candidate will review validation artifacts, support SOP development, manage risk controls, and participate in inspections. Strong writing, analytical, and communication skills are essential.