Head of QA Operations (Assoc Dir level)
Novartis
September 01, 2026
Full-time
On-site
Indianapolis, IN
Operations
Role: Head of QA Operations at Novartis' Indianapolis Radioligand Therapy (RLT) manufacturing site, overseeing quality assurance for drug product manufacturing, quality control, and product disposition. Responsibilities: lead QA teams, ensure compliant and timely product disposition, drive inspection readiness and operational excellence, manage investigations and change controls, support validation activities, and partner cross-functionally to support manufacturing goals and continuous improvement. Requirements: Bachelor's degree in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related; 10+ years in pharmaceutical QA, QC, or GxP operations; experience leading QA organizations and supporting aseptic manufacturing; strong knowledge of GMPs, regulatory standards, and audit management. Preferred: experience in advanced therapies such as Radioligand or Cell and Gene Therapies, and expertise in Lean, Six Sigma methodologies. HighValue: biologics or advanced therapy platforms, aseptic drug manufacturing, GxP compliance, regulatory inspections, and quality leadership within regulated biotech/pharma industries. WorkSetup: on-site in Indianapolis, Indiana.