Manager, GMP Inspection Management
Core
Manage site quality operations, self-inspection programs, and readiness for health authority inspections for radiopharmaceutical manufacturing.
Role type
Manager, Quality Assurance (GMP)
Builds
Compliance-ready manufacturing sites for oncology radiopharmaceuticals
Domain
Biotechnology / Oncology / Radiopharmaceuticals
Deliverable
client delivery
Required skills
GMP audit leadership, regulatory compliance expertise, inspection readiness planning, cross-functional team leadership, regulatory correspondence, risk assessment, change management
Preferred skills
Clinical/commercial manufacturing QA background, FDA/EMA inspection hosting experience
Technologies
None stated
Responsibilities
Lead site inspection readiness for health authority audits, develop annual inspection readiness plans, participate in and lead responses to corporate and regulatory inspections, manage the Self-Inspection Program, lead regulatory surveillance activities, provide compliance guidance on cGMP requirements, support regulatory agency correspondence and filings, coordinate APQR documents
Seniority
Manager, hands-on IC
