What are the responsibilities and job description for the Associate Director of Quality Operations - Pharmaceutical Manufacturing position at Pharmaceutical Manufacturing?
- Responsible for Quality Operations oversight and day-to-day Quality management related to isotope and Radiopharmaceutical drug product manufacturing at the Indianapolis facility.
- Ensure adherence to applicable GMP regulations and company policies and procedures.
- Collaborate with other business leaders across the organization to support the development, continuous improvement and lifecycle management of GMP policies and procedures.
- Lead the implementation of site readiness for FDA Pre-Approval Inspection Pre-license inspection.
- Support compliance audits and regulatory inspections by competent regulatory authority (e.g., FDA, EMA, PMDA, etc.).
- Work collaboratively with Leads from Facilities and Engineering, Manufacturing, IT, Clinical Operations, Logistics, and MS&T, to ensure the ongoing qualified and operational readiness for commercial manufacturing at the facility.
Salary : $180,000 - $220,000
