Senior Manager, GxP IT Quality & Compliance

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company…

Paid parental leave

Paid time off and holidays

Job summary

Legend Biotech, a global biopharma company, seeks a Sr Manager, Quality IT based in Bridgewater, NJ.

You will provide IT Quality oversight for GxP systems across the lifecycle, ensure compliance with FDA/EMEA guidelines, and lead validation, change control, SOPs, and regulatory audits.

This role requires a BS in Science/IT/Engineering, 10+ years in biotech/pharma with 5+ years in leadership, strong communication, and proven experience with QMS, LIMS, and ERP systems.

Qualifications

• Bachelor's degree in Science, IT, Engineering or equivalent.
• 10+ years in pharma/biotech/medical devices.
• 5+ years of leadership experience.
• Experience with GxP regulations and audits.
• Strong communication with stakeholders and cross-functional teams.
• Proficiency with QMS, documentation control, validation, change control.

Responsibilities

• Provide IT Quality oversight for GxP systems lifecycle.
• Ensure systems comply with FDA, EMEA and other regulatory requirements.
• Develop SOPs and supplier audit programs.
• Lead system upgrades and validation activities.
• Review change controls and ensure data integrity.
• Train IT personnel on GxP requirements.
• Support inspection readiness and regulatory inspections.
• Collaborate with cross-functional teams to define user requirements.
• Maintain documentation and risk assessments.
• Drive continuous improvement in quality programs.

Skills

Stakeholder management

Regulatory knowledge

Quality Assurance

IT Quality systems

GxP regulatory compliance

Communication skills

AI literacy

Education

Bachelor's degree in Science/IT/Engineering

Advanced degree preferred

Tools

QMS software

LIMS

Veeva

ERP (SAP considered a plus)

Job description

Legend Biotech, a global biopharma company, seeks a Sr Manager, Quality IT based in Bridgewater, NJ.

You will provide IT Quality oversight for GxP systems across the lifecycle, ensure compliance with FDA/EMEA guidelines, and lead validation, change control, SOPs, and regulatory audits.

This role requires a BS in Science/IT/Engineering, 10+ years in biotech/pharma with 5+ years in leadership, strong communication, and proven experience with QMS, LIMS, and ERP systems.