Associate Director, GxP Compliance and Auditing
Legend Biotech
August 07, 2026
On-site
Bridgewater, NJ
Operations
Associate Director, GxP Compliance and Auditing (Global Quality) — Bridgewater, NJ
Role Overview
Strategically lead development, implementation, and continuous improvement of global GxP compliance and auditing programs.
Key Responsibilities
- Own global GxP compliance and auditing programs; serve as Compliance & Auditing Business Process/System Owner.
- Define and maintain compliance processes, procedures, tools, and training for internal/external auditing, inspection readiness, QMR, regulatory trends, and quality planning.
- Develop/improve compliance systems; identify IT solutions supporting compliance/auditing.
- Apply global regulations; use risk-based methodology and drive quality metrics, trends, governance, and continuous improvement.
- Lead Inspection Readiness Program (training, pre-audit preparation, hosting, close-out); maintain inspection risk assessments/scorecards; provide PAI/PLI/audit training.
- Lead/support internal audits and host/co-host external health authority inspections; facilitate inspections; manage responses to observations.
- Run internal/external audit schedules; provide management recommendations.
- Execute external audit programs (vendor/third-party); prepare audit reports; manage CAPAs/regulatory responses.
- Perform vendor risk assessments; oversee supplier qualification/approval/risk; execute supplier qualification activities.
- Lead regulatory intelligence monitoring and cross-functional program; oversee QSMR and quality planning.
- Provide QA advice to stakeholders; maintain cGxP SOPs and compliance-aligned quality documents.
Requirements
- Bachelor’s in scientific/technical discipline (MS/MBA/PhD preferred). Minimum 12 years relevant GxP experience; 5+ years leadership/planning.
- Proven internal/external audit and health authority inspection experience; strong global GxP regulations expertise (21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA, China GMP).
- Regulatory intelligence experience; data-driven, risk-based decision-making; strong communication; IT/Digital compliance tool experience preferred.
- 20% travel required.
Benefits
Base pay $168,372–$220,988; performance bonus/equity (eligible roles). Medical/dental/vision; 401(k) match (day one); 8 weeks paid parental leave after 3 months; PTO including 11 holidays; and additional voluntary benefits.
Role Overview
Strategically lead development, implementation, and continuous improvement of global GxP compliance and auditing programs.
Key Responsibilities
- Own global GxP compliance and auditing programs; serve as Compliance & Auditing Business Process/System Owner.
- Define and maintain compliance processes, procedures, tools, and training for internal/external auditing, inspection readiness, QMR, regulatory trends, and quality planning.
- Develop/improve compliance systems; identify IT solutions supporting compliance/auditing.
- Apply global regulations; use risk-based methodology and drive quality metrics, trends, governance, and continuous improvement.
- Lead Inspection Readiness Program (training, pre-audit preparation, hosting, close-out); maintain inspection risk assessments/scorecards; provide PAI/PLI/audit training.
- Lead/support internal audits and host/co-host external health authority inspections; facilitate inspections; manage responses to observations.
- Run internal/external audit schedules; provide management recommendations.
- Execute external audit programs (vendor/third-party); prepare audit reports; manage CAPAs/regulatory responses.
- Perform vendor risk assessments; oversee supplier qualification/approval/risk; execute supplier qualification activities.
- Lead regulatory intelligence monitoring and cross-functional program; oversee QSMR and quality planning.
- Provide QA advice to stakeholders; maintain cGxP SOPs and compliance-aligned quality documents.
Requirements
- Bachelor’s in scientific/technical discipline (MS/MBA/PhD preferred). Minimum 12 years relevant GxP experience; 5+ years leadership/planning.
- Proven internal/external audit and health authority inspection experience; strong global GxP regulations expertise (21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA, China GMP).
- Regulatory intelligence experience; data-driven, risk-based decision-making; strong communication; IT/Digital compliance tool experience preferred.
- 20% travel required.
Benefits
Base pay $168,372–$220,988; performance bonus/equity (eligible roles). Medical/dental/vision; 401(k) match (day one); 8 weeks paid parental leave after 3 months; PTO including 11 holidays; and additional voluntary benefits.