Regional Manager, Quality Management
Core
Develops and implements quality policies and processes to ensure PET radiopharmaceutical products comply with regulatory standards and specifications.
Role type
Regional Manager, Quality Management
Builds
PET radiopharmaceuticals for patient disease diagnosis, staging, and monitoring
Domain
Pharmaceutical manufacturing / Radiopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA regulatory compliance, cGMP, validation protocols, batch record review, product disposition, investigation and remediation of manufacturing issues, change control, data trend analysis, resource management
Preferred skills
Pharmaceutical industry experience, quality management role experience, leadership, MS Office proficiency, ability to travel
Technologies
MS Word, PowerPoint, Excel
Responsibilities
Provide overall direction and management of the QA function for assigned PET manufacturing sites; ensure identity, strength, quality, and purity of released drug products; interact with regulatory agencies to close FDA commitments; assess data to identify trends and develop corrective actions; manage monetary assets and resources to optimize cost effectiveness; approve change control documents and initiate investigations; make hiring decisions for direct reports.
Seniority
Manager, supervises professional employees and front-line supervisors
