Director GCP/GVP Inspection Readiness and Management

Role: Lead global GCP/GVP Inspection Readiness and Management for a biopharma focused on autoimmune diseases, overseeing regulatory inspection preparedness and internal quality audits. Responsibilities: develop and execute inspection readiness strategies, serve as primary Inspection Lead for agencies like FDA, EMA, MHRA, PMDA, and manage internal audits; collaborate with Clinical Operations, Pharmacovigilance, Regulatory Affairs, Data Management, and Quality to ensure compliance and effective inspection responses; monitor inspection trends, develop risk mitigation plans, and oversee CAPAs. Requirements: Bachelor's in life sciences or related field; 12+ years in regulated pharma/biotech industry, with at least 5 years in leadership; deep knowledge of GCP, GVP, ICH, 21 CFR Part 11, and global regulatory standards; proven experience supporting multiple health authority inspections and leading cross-functional teams. HighValue: global regulatory inspection management, GCP/GVP compliance, biotech/pharma industry experience, leadership in inspection readiness, international travel (~25-50%). WorkSetup: not specified, but travel indicates some flexibility.