Senior Manager, Inspection Management
Core
Planning, logistics, and management of regulatory health authority inspections (FDA, EMA) for R&D programs to ensure compliance and inspection readiness.
Role type
Senior Manager, Regulatory Inspection Management
Builds
Inspection readiness and compliance for R&D programs
Domain
Biopharma / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory inspection planning, stakeholder relationship management, GxP regulations knowledge, CAPA management, inspection readiness training, post-inspection analysis, regulatory intelligence
Preferred skills
FDA/EU/ICH GCP guidelines, computerized systems regulations, CRO/vendor management, regulatory intelligence experience
Technologies
None explicitly stated
Responsibilities
Plan and coordinate GCP/GVP/GLP regulatory authority inspections; Manage inspection readiness activities including mock inspections and risk assessments; Provide guidance on responses to inspection observations; Lead post-inspection lessons learned sessions; Contribute to regulatory intelligence briefing reports; Mentor junior staff
Seniority
Senior, hands-on management with mentorship
