Associate Director, GxP Compliance and Auditing
Legend Biotech
August 29, 2026
On-site
Bridgewater, NJ
Operations
Associate Director, GxP Compliance and Auditing (Global Quality) — Bridgewater, NJ.
Role Overview
- Strategic leader for development, implementation, and continuous enhancement of global GxP compliance and auditing programs (internal/external audits, inspection readiness/logistics, supplier quality management, regulatory intelligence, Quality Management Review oversight, and quality planning). People-manager of one direct report; leads internal audits at Somerset and Raritan CARVYKTI sites and supports inspection readiness with on-site travel.
Key Responsibilities
- Own global GxP compliance/auditing programs; act as Global Business Process and System Owner.
- Define/maintain compliance processes, tools, and training; develop/maintain IT solutions supporting compliance.
- Interpret global regulations; apply risk-based approach; drive quality metrics, governance, and continuous improvement.
- Lead Inspection Readiness Program; maintain inspection risk scorecards; provide PAI/PLI training.
- Host/support internal audits and external health authority/party inspections; manage responses to observations; oversee CAPAs.
- Run internal audit program; generate annual internal/external audit schedules.
- Execute external vendor/third-party audit programs; oversee supplier audits/qualification and risk assessments.
- Lead Regulatory Intelligence; execute QSMR and Quality Planning.
Requirements
- Bachelor’s in scientific/technical field required; advanced degree preferred.
- 12+ years GxP experience; 5+ years leadership; strong internal/external audit and inspection readiness experience. Cell therapy/aseptic/bio/manufacturing compliance strongly preferred; GMP/GDP/GCP/GLP experience preferred.
- 20% travel.
- Deep expertise in global GxP regulations (e.g., 21 CFR, ICH Q10, EU GMP/GDP, Annex 11/Part 11, PIC/S, MHRA, China GMP).
Benefits (as stated)
- Medical/dental/vision; 401(k) match (vests day one); 8 weeks paid parental leave after 3 months; paid time off; additional voluntary benefits (e.g., disability, legal assistance, supplemental insurance).
Role Overview
- Strategic leader for development, implementation, and continuous enhancement of global GxP compliance and auditing programs (internal/external audits, inspection readiness/logistics, supplier quality management, regulatory intelligence, Quality Management Review oversight, and quality planning). People-manager of one direct report; leads internal audits at Somerset and Raritan CARVYKTI sites and supports inspection readiness with on-site travel.
Key Responsibilities
- Own global GxP compliance/auditing programs; act as Global Business Process and System Owner.
- Define/maintain compliance processes, tools, and training; develop/maintain IT solutions supporting compliance.
- Interpret global regulations; apply risk-based approach; drive quality metrics, governance, and continuous improvement.
- Lead Inspection Readiness Program; maintain inspection risk scorecards; provide PAI/PLI training.
- Host/support internal audits and external health authority/party inspections; manage responses to observations; oversee CAPAs.
- Run internal audit program; generate annual internal/external audit schedules.
- Execute external vendor/third-party audit programs; oversee supplier audits/qualification and risk assessments.
- Lead Regulatory Intelligence; execute QSMR and Quality Planning.
Requirements
- Bachelor’s in scientific/technical field required; advanced degree preferred.
- 12+ years GxP experience; 5+ years leadership; strong internal/external audit and inspection readiness experience. Cell therapy/aseptic/bio/manufacturing compliance strongly preferred; GMP/GDP/GCP/GLP experience preferred.
- 20% travel.
- Deep expertise in global GxP regulations (e.g., 21 CFR, ICH Q10, EU GMP/GDP, Annex 11/Part 11, PIC/S, MHRA, China GMP).
Benefits (as stated)
- Medical/dental/vision; 401(k) match (vests day one); 8 weeks paid parental leave after 3 months; paid time off; additional voluntary benefits (e.g., disability, legal assistance, supplemental insurance).