Associate Director, GxP Compliance and Auditing
Legend Biotech
7 hours ago
Remote friendly (Bridgewater, NJ)
United States
Operations
Role Overview
The Associate Director, GxP Compliance and Auditing serves as a strategic leader for the development, implementation, and continuous enhancement of global GxP compliance and auditing programs. Oversees internal/external audits, inspection readiness/logistics, supplier quality management, regulatory intelligence monitoring, Quality Management Review oversight, and quality planning. People-manager role (one direct report). Conducts internal audits at Somerset and Raritan CARVYKTI sites, performs external third-party/supplier audits, and supports inspection readiness across Somerset and Raritan manufacturing facilities with on-site travel expected.
Key Responsibilities
- Lead global GxP compliance and auditing programs; serve as Global Business Process/System Owner for Compliance and Auditing.
- Define/maintain compliance processes, procedures, tools, and training for audits, inspection readiness, QMR, emerging regulations, regulatory trends, and quality planning.
- Develop and continuously improve compliance processes/systems; identify/maintain IT solutions supporting compliance.
- Interpret/apply global regulations; use a risk-based approach; drive quality metrics, governance, and continuous improvement.
- Drive inspection readiness program (training, pre-audit preparation, hosting, close-out); maintain inspection risk assessment processes/scorecards; provide PAI/PLI and audit training.
- Host/support internal audits and external Health Authority inspections; facilitate inspections; manage response to audit observations.
- Lead internal audit program; generate/execute annual audit schedules; provide management recommendations; manage audit outcomes (CAPAs/regulatory responses).
- Manage external audit programs (vendors/third parties); oversee supplier qualification and risk assessment; execute qualification activities (e.g., Apheresis Centers).
- Lead regulatory intelligence program; oversee QSMR and quality planning; provide QA advice across manufacturing/CROs/CMOs; maintain cGxP SOPs and compliance-aligned quality documents.
Requirements
- BS in a scientific/technical discipline required; MS/MBA/PhD preferred.
- 12+ years relevant GxP experience; 5+ years leadership experience (senior-level planning/execution).
- Proven experience with internal audits, external audits, and supporting health authority inspections; global process implementation and cross-site alignment.
- Strong GxP/regulatory knowledge (e.g., 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA, China GMP) and audit report/observation writing with closure follow-through.
- Regulatory intelligence experience; audit hosting (front-room/back-room).
- Strong strategic, risk-based, data-driven judgment; excellent communication/interpersonal skills; analytical problem-solving.
Preferred/Additional Skills (if applicable)
- Experience in aseptic manufacturing/biologics/advanced therapies (quality assurance, manufacturing compliance, clinical quality, or cell therapy).
- Experience across all GxP functions (GMP, GDP, GCP, GLP).
Benefits/Application Instructions
- Not included in the provided text (beyond an eligibility note for permanent full-time employees).
The Associate Director, GxP Compliance and Auditing serves as a strategic leader for the development, implementation, and continuous enhancement of global GxP compliance and auditing programs. Oversees internal/external audits, inspection readiness/logistics, supplier quality management, regulatory intelligence monitoring, Quality Management Review oversight, and quality planning. People-manager role (one direct report). Conducts internal audits at Somerset and Raritan CARVYKTI sites, performs external third-party/supplier audits, and supports inspection readiness across Somerset and Raritan manufacturing facilities with on-site travel expected.
Key Responsibilities
- Lead global GxP compliance and auditing programs; serve as Global Business Process/System Owner for Compliance and Auditing.
- Define/maintain compliance processes, procedures, tools, and training for audits, inspection readiness, QMR, emerging regulations, regulatory trends, and quality planning.
- Develop and continuously improve compliance processes/systems; identify/maintain IT solutions supporting compliance.
- Interpret/apply global regulations; use a risk-based approach; drive quality metrics, governance, and continuous improvement.
- Drive inspection readiness program (training, pre-audit preparation, hosting, close-out); maintain inspection risk assessment processes/scorecards; provide PAI/PLI and audit training.
- Host/support internal audits and external Health Authority inspections; facilitate inspections; manage response to audit observations.
- Lead internal audit program; generate/execute annual audit schedules; provide management recommendations; manage audit outcomes (CAPAs/regulatory responses).
- Manage external audit programs (vendors/third parties); oversee supplier qualification and risk assessment; execute qualification activities (e.g., Apheresis Centers).
- Lead regulatory intelligence program; oversee QSMR and quality planning; provide QA advice across manufacturing/CROs/CMOs; maintain cGxP SOPs and compliance-aligned quality documents.
Requirements
- BS in a scientific/technical discipline required; MS/MBA/PhD preferred.
- 12+ years relevant GxP experience; 5+ years leadership experience (senior-level planning/execution).
- Proven experience with internal audits, external audits, and supporting health authority inspections; global process implementation and cross-site alignment.
- Strong GxP/regulatory knowledge (e.g., 21 CFR, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA, China GMP) and audit report/observation writing with closure follow-through.
- Regulatory intelligence experience; audit hosting (front-room/back-room).
- Strong strategic, risk-based, data-driven judgment; excellent communication/interpersonal skills; analytical problem-solving.
Preferred/Additional Skills (if applicable)
- Experience in aseptic manufacturing/biologics/advanced therapies (quality assurance, manufacturing compliance, clinical quality, or cell therapy).
- Experience across all GxP functions (GMP, GDP, GCP, GLP).
Benefits/Application Instructions
- Not included in the provided text (beyond an eligibility note for permanent full-time employees).