Senior Director, R&D GxP Audit
Core
Lead global strategy and execution of internal and external GxP audit programs for R&D Quality, ensuring compliance with regulations and industry standards across clinical trials, pharmacovigilance, and vendor oversight.
Role type
Senior Director, R&D GxP Audit
Builds
Independent assurance systems for R&D Quality compliance and inspection readiness
Domain
Biotechnology / Pharmaceutical R&D / Regulatory Quality
Deliverable
client delivery
Required skills
GxP auditing expertise, regulatory knowledge (GCP/GLP/GVP), leadership of audit organizations, risk-based audit strategy, supplier oversight, CAPA management, executive communication
Preferred skills
MBA or MS in Operations/Engineering, complex audit program leadership, risk management systems, inspection readiness, executive influencing
Technologies
None stated
Responsibilities
Develop and execute global risk-based GxP audit strategy; Lead internal, external, and supplier audit programs; Serve as strategic advisor on compliance trends and systemic risks; Oversee audits of clinical trial processes, pharmacovigilance systems, and laboratories; Use data analytics to prioritize audits based on business criticality; Present audit trends and risk insights to executive leadership; Recruit, develop, and mentor audit professionals
Seniority
Senior Director, strategic leadership & mentorship
