Site QC Head (Associate Director)

Role: Site QC Head leading the Quality Control organization at Novartis's Indianapolis Radioligand Therapy manufacturing site. Responsibilities: oversee testing and release of materials/products in compliance with regulations, establish and optimize QC laboratory processes, manage validations, investigations, and change controls, lead inspection readiness, and foster a culture of GMP compliance and continuous quality improvement. Requirements: Bachelor's in Chemistry, Biology, Pharmacy, or Engineering; 10+ years in pharma/biotech regulated industry, including 5+ years in leadership and QC management; strong knowledge of cGMP, QC operations, and aseptic manufacturing; experience with regulatory inspections and investigations. Preferred: experience in Radioligand Therapy manufacturing or advanced therapies; expertise in process improvement methodologies like Lean or Six Sigma. HighValue: leadership in QC for biologics/advanced therapies, cGMP compliance, regulatory inspections, GMP laboratory operations, and investigations. WorkSetup: Indianapolis site; travel not specified.