Sr IT Quality Leader – GxP Compliance & Validation

Legend Biotech USA; Bridgewater (MA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Employee benefits

Job summary

Legend Biotech is seeking a Sr Manager, Quality IT based in Bridgewater, NJ to provide IT quality oversight for GxP systems across the product lifecycle.

You will ensure compliance with FDA regulations, EU guidelines, and industry standards, lead validation, change control, and SOP development, and collaborate with cross-functional teams to optimize systems while supporting inspections and regulatory programs.

Qualifications

• Bachelor's degree in science, IT or engineering.
• 10+ years in pharma/biotech/medical device with at least 5 years in leadership.
• Proficiency in GxP regulations and QA processes; strong communication.

Responsibilities

• Ensure GxP IT systems, processes and records adhere to FDA/EMEA requirements.
• Provide IT quality oversight for system validation and changes.
• Develop and enforce SOPs for IT quality at Legend.
• Collaborate with cross-functional teams for upgrades and user requirements.
• Maintain documentation, audits, data integrity, and support inspections.

Skills

Regulatory compliance

IT quality oversight

Leadership

Cross-functional collaboration

Education

Bachelor's degree in science/IT/engineering

Tools

QMS software

LIMS

Veeva

SAP

Job description

Legend Biotech is seeking a Sr Manager, Quality IT based in Bridgewater, NJ to provide IT quality oversight for GxP systems across the product lifecycle.

You will ensure compliance with FDA regulations, EU guidelines, and industry standards, lead validation, change control, and SOP development, and collaborate with cross-functional teams to optimize systems while supporting inspections and regulatory programs.