Senior Quality IT Leader, GxP Compliance & Validation

Socket.dev; 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 1:

Eight weeks of paid parental leave

Job summary

Legend Biotech is seeking a Sr Manager, Quality IT to lead IT QA for GxP systems in Bridgewater, NJ. You will ensure compliance with FDA/EMEA regulations, manage validation activities, and drive continuous improvement across CSV and SDLC processes.

You will partner with Quality, IT and GMP teams to implement SOPs, manage audits, and support regulatory inspections, while mentoring staff and advancing quality metrics within a global biotech environment.

Qualifications

• Bachelor’s degree in Science, IT, Engineering or equivalent technical discipline; advanced degree preferred.
• 10+ years of relevant work experience within a pharmaceutical/biotech/medical device industry with at least 5 years in leadership.
• Experience collaborating and communicating effectively with internal and external stakeholders.
• Proficiency in QMS software, document control, validation tools, change control systems, LIMS, Veeva, ERP systems (SAP considered a plus).
• Ability to clearly represent compliance requirements and drive continuous improvement using risk-based approaches.
• Experience in Quality Assurance, Quality Systems and/or IT; strong knowledge of global GxP regulations.

Responsibilities

• Provide IT Quality oversight for GxP System enhancement and validation activities, including documentation and change controls.
• Maintain compliance across CSV, SDLC and regulatory requirements (FDA/EMEA).
• Develop and enforce SOPs; collaborate with cross-functional teams for system upgrades and supplier audits.
• Review IT systems change management documents and authorize system use upon verification of requirements.
• Support inspection readiness and respond to regulatory inspections as required.
• Monitor data integrity, investigate issues, and drive system improvement across Legend IT.
• Train IT personnel on GxP requirements and support QMR metrics.

Skills

Communication

QMS Software

GxP Regulations

Quality Assurance

IT Knowledge

Regulatory Inspection Experience

Education

Bachelor’s degree in Science/IT/Engineering

Tools

LIMS

Veeva

SAP

Job description

Legend Biotech is seeking a Sr Manager, Quality IT to lead IT QA for GxP systems in Bridgewater, NJ. You will ensure compliance with FDA/EMEA regulations, manage validation activities, and drive continuous improvement across CSV and SDLC processes.

You will partner with Quality, IT and GMP teams to implement SOPs, manage audits, and support regulatory inspections, while mentoring staff and advancing quality metrics within a global biotech environment.