Senior Quality IT Manager – GxP Compliance

Legend Biotech; Bridgewater (MA); On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Vacation time and holidays

Job summary

Legend Biotech, a global biotechnology company headquartered in Bridgewater, NJ, seeks a Sr Manager, Quality IT to lead IT quality oversight for GxP systems across the enterprise. You will interpret regulations, define QA requirements, and implement compliant processes aligned with FDA, EU Annex 11, and global guidelines.

The role combines quality and IT leadership, requiring strong collaboration with cross-functional teams, risk-based decision making, and a focus on data integrity, change

Qualifications

• Bachelor's degree in Science, IT, Engineering or equivalent.
• 10+ years in pharma/biotech with min 5 yrs leadership.
• Experience collaborating with internal and external stakeholders
• Proficiency in QMS software, document control, validation and change control
• Knowledge of global GxP regulations (US essential; EU/China a plus)

Responsibilities

• Ensure GxP IT systems meet Legend CSV, SDLC and regulatory requirements.
• Oversee GxP system enhancements, validation, documentation and change controls.
• Develop and enforce SOPs; coordinate system upgrades and user requirements.
• Maintain audit readiness and respond to inspections.
• Mentor IT staff on GxP standards and risk-based compliance.

Skills

Effective communication

Leadership experience

GxP regulations knowledge

Quality systems

IT governance

Education

Bachelor's degree in Science/IT/Engineering

Advanced degree preferred

Tools

QMS software

Document control

Validation tools

LIMS

Veeva

ERP (SAP)

Job description

Legend Biotech, a global biotechnology company headquartered in Bridgewater, NJ, seeks a Sr Manager, Quality IT to lead IT quality oversight for GxP systems across the enterprise. You will interpret regulations, define QA requirements, and implement compliant processes aligned with FDA, EU Annex 11, and global guidelines.

The role combines quality and IT leadership, requiring strong collaboration with cross-functional teams, risk-based decision making, and a focus on data integrity, change