GxP IT Quality Specialist: Validation & Compliance

BioNJ Inc.; Bridgewater Township (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

Legend Biotech, headquartered in Bridgewater, New Jersey, is seeking a Sr. Specialist, IT Quality to provide IT Quality oversight for GxP computerized systems across the lifecycle, ensuring compliance with FDA, EU, and GAMP 5 guidance.

The role involves risk assessment, validation, and working with IT, Validation, Quality, and business owners. The position requires 7+ years in the pharma/biotech space, strong documentation skills, and the ability to communicate with internal stakeholders and

Qualifications

• Bachelor's degree in Science, IT, Engineering, or equivalent.
• Advanced degree or relevant certification preferred.
• Minimum 7 years in pharma/biotech/medical device with 4+ years in QA, CV/CSV, IT Quality, or regulated lifecycles.

Responsibilities

• Oversee GxP IT systems compliant with CSV/CSA and SDLC.
• Review validation plans, risk assessments, and test reports.
• Collaborate with IT, Validation, Quality, and system owners for maintenance and upgrades.
• Develop and implement SOPs, templates, and standards.
• Support audits, inspections, and regulatory responses.

Skills

GxP knowledge

Regulatory compliance

Quality assurance

Documentation and writing

Communication with stakeholders

Education

Bachelor's degree in Science/IT/Engineering

Advanced degree or professional certification preferred

Tools

QMS

Document management

Validation management

LIMS

Veeva / ERP / SAP

Job description

Legend Biotech, headquartered in Bridgewater, New Jersey, is seeking a Sr. Specialist, IT Quality to provide IT Quality oversight for GxP computerized systems across the lifecycle, ensuring compliance with FDA, EU, and GAMP 5 guidance.

The role involves risk assessment, validation, and working with IT, Validation, Quality, and business owners. The position requires 7+ years in the pharma/biotech space, strong documentation skills, and the ability to communicate with internal stakeholders and