Manager, Global Inspection Management

Overview

• Lead global GMP inspection readiness and management programs for internal and external manufacturing sites.
• Ensure proactive, risk-based inspection readiness across manufacturing and testing operations.
• Develop inspection storyboards, mock protocols, and response templates for regulatory inspections.
• Monitor and report inspection readiness performance metrics to drive continuous improvement.
• Collaborate with cross-functional teams to align on inspection strategies and governance.
• Deliver training programs for SMEs and inspection teams to enhance readiness.
• Analyze inspection trends and regulatory intelligence to mitigate risks effectively.
• Support regulatory inspections, including logistics, real-time coordination, and follow-up activities.

Key Responsibilities & Duties

• Implement and oversee a comprehensive global GMP inspection management framework.
• Coordinate inspection readiness initiatives across internal and external manufacturing sites.
• Develop and maintain inspection playbooks and response templates for regulatory inspections.
• Support regulatory inspections (FDA, EMA, PMDA) with coordination and response management.
• Collaborate with Quality, Manufacturing, and Supply Chain teams to ensure CMO sites are inspection ready.
• Deliver training programs and analyze trends to inform risk mitigation strategies.
• Drive continuous improvement in inspection readiness processes and tools.
• Participate in cross-functional teams to align on inspection strategy and governance.

Job Requirements

• Bachelor’s degree in Life Sciences or related field required.
• Minimum 10 years of experience in GMP compliance, quality assurance, or regulatory affairs.
• Proven expertise in leading global regulatory inspections and readiness programs.
• Strong knowledge of global GMP regulations and inspection practices.
• Experience with biologics or gene therapy manufacturing preferred.
• Prior experience managing complex supply chains and working with global CMOs.
• Familiarity with digital tools for inspection management and quality systems.
• Excellent communication and project management skills in a matrixed organization.
• Willingness to travel up to 25% domestically and internationally.