Sr. Manager Quality IT
Legend Biotech
August 19, 2026
On-site
Bridgewater, NJ
IT
Sr Manager, Quality IT (Quality IT) — Bridgewater, NJ
Role Overview
- Provide IT Quality oversight for implementation and lifecycle management of GxP IT systems.
- Ensure GxP electronic systems comply with Electronic Records/Electronic Signatures, Data Integrity, and applicable cGMP/GCP/GLP guidance (e.g., FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA, GAMP5).
Key Responsibilities
- Ensure GxP IT systems/processes/records follow CSV/SDLC procedures and regulatory requirements.
- Provide oversight for GxP system enhancements/validation (documentation, change controls).
- Coordinate Software Validation Plans and IQ/OQ/PQ protocols/reports; support risk assessments, SOPs, and traceability matrices.
- Maintain software master files/profiles/tables; harmonize across systems.
- Review/approve IT change management; authorize use after verification.
- Monitor error reports, assure data integrity, investigate issues, and recommend changes.
- Support IT supplier audit program and ensure CAPAs/deviations are tracked and remediated.
- Provide quality oversight for SOPs governing IT system use/validation; identify/mitigate GxP IT risks.
- Train stakeholders; support continuous improvement and inspection readiness; support QMR metrics.
Requirements / Qualifications
- BS in Science/IT/Engineering or equivalent (advanced degree preferred).
- 10+ years in pharma/biotech or medical device; 5+ years leadership.
- Experience with Quality Assurance/Systems and/or IT.
- Strong global GxP regulatory knowledge (US required; EU/China/GTP plus).
- Proficiency with QMS/document control/validation tools/change control; LIMS, Veeva, ERP (SAP plus).
- Excellent communication; risk-based, continuous-improvement mindset; prioritize multiple projects.
- Plus: inspection experience; clinical/GMP/GLP audit experience.
Benefits (selected)
- Medical, dental, vision; 401(k) match (vests day one).
- 8 weeks paid parental leave after 3 months.
- Paid time off incl. vacation, personal, sick, floating holidays, and 11 company holidays.
- Base pay range: $127,313–$167,099 USD; performance bonus/equity may be available.
Role Overview
- Provide IT Quality oversight for implementation and lifecycle management of GxP IT systems.
- Ensure GxP electronic systems comply with Electronic Records/Electronic Signatures, Data Integrity, and applicable cGMP/GCP/GLP guidance (e.g., FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA, GAMP5).
Key Responsibilities
- Ensure GxP IT systems/processes/records follow CSV/SDLC procedures and regulatory requirements.
- Provide oversight for GxP system enhancements/validation (documentation, change controls).
- Coordinate Software Validation Plans and IQ/OQ/PQ protocols/reports; support risk assessments, SOPs, and traceability matrices.
- Maintain software master files/profiles/tables; harmonize across systems.
- Review/approve IT change management; authorize use after verification.
- Monitor error reports, assure data integrity, investigate issues, and recommend changes.
- Support IT supplier audit program and ensure CAPAs/deviations are tracked and remediated.
- Provide quality oversight for SOPs governing IT system use/validation; identify/mitigate GxP IT risks.
- Train stakeholders; support continuous improvement and inspection readiness; support QMR metrics.
Requirements / Qualifications
- BS in Science/IT/Engineering or equivalent (advanced degree preferred).
- 10+ years in pharma/biotech or medical device; 5+ years leadership.
- Experience with Quality Assurance/Systems and/or IT.
- Strong global GxP regulatory knowledge (US required; EU/China/GTP plus).
- Proficiency with QMS/document control/validation tools/change control; LIMS, Veeva, ERP (SAP plus).
- Excellent communication; risk-based, continuous-improvement mindset; prioritize multiple projects.
- Plus: inspection experience; clinical/GMP/GLP audit experience.
Benefits (selected)
- Medical, dental, vision; 401(k) match (vests day one).
- 8 weeks paid parental leave after 3 months.
- Paid time off incl. vacation, personal, sick, floating holidays, and 11 company holidays.
- Base pay range: $127,313–$167,099 USD; performance bonus/equity may be available.