Regional Manager, Quality Management
Core
Provides strategic oversight and leadership for Quality Assurance functions at PET radiopharmaceutical manufacturing sites to ensure regulatory compliance and product quality.
Role type
Senior 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 -> physical/clinical work (manufacturing oversight)
Required skills
FDA regulatory compliance, cGMP knowledge, validation practices, root cause analysis, change control management, resource optimization, strategic alliance building
Preferred skills
Pharmaceutical industry experience, quality management role experience, MS Office proficiency, travel adaptability
Technologies
MS Word, PowerPoint, Excel
Responsibilities
Direct QA function at assigned PET manufacturing sites, review and approve batch records and product disposition, investigate and remediate manufacturing issues, train QA staff on verification and approval processes, interact with regulatory agencies to close FDA commitments, assess data to identify trends and develop corrective actions, manage monetary assets and resources for cost effectiveness, approve change control documents and initiate investigations.
Seniority
Senior, hands-on IC with management responsibilities
