Director, GCP Inspection Management, Americas

About the role

Leads inspection readiness and the hosting of regulatory GCP inspections across the Americas, and builds a proactive, risk-based inspection strategy for a growing cancer-focused drug developer.

What you will do

• Direct a team of quality staff and consultants handling inspection readiness, coordination and hosting
• Create and execute a proactive inspection strategy based on risk, with risk analyses and mitigation plans
• Work with cross-functional leaders and external partners on one unified inspection approach
• Track inspection forecasts and outcomes, and ensure commitments and CAPAs close on time
• Run quarterly cross-functional inspection oversight meetings and share lessons learned
• Represent R&D quality in meetings and act as delegate for the executive director

What they look for

• Experience managing GCP inspections by health authorities such as FDA, EMA, PMDA or TGA
• Strong grasp of global regulations and the cultural awareness to work across regions
• Proven ability to build and support highly effective teams
• Skill at resolving complex problems through in-depth analysis of many factors
• Background in quality within research and development