Head of QA Operations (Assoc Dir level)
$138,600–$257,400 year
On-siteIndianapolis, Indiana, United States
Job Summary
Lead the QA Operations organization providing quality oversight for Drug Product Manufacturing and Quality Control operations, including Shop Floor QA, QA Engineering, and final product disposition. Drive quality oversight across manufacturing to promote inspection readiness, lead investigations, deviations, and change controls, and ensure preparation of validation plans. Manage resource allocation, capacity planning, and escalation support for FDA interactions and commercial product field actions while building high-performing teams and strengthening site quality culture. Monitor performance metrics to drive continuous improvement initiatives. This leadership role supports Novartis' Indianapolis Radioligand Therapy manufacturing site, partnering cross-functionally to ensure reliable delivery of innovative therapies to patients.
Required Qualifications
- Bachelor of Science in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related experience
- 10+ years of experience in Quality Assurance, Quality Control, Quality Systems, Compliance, or operational GxP area (Manufacturing / Development) within the pharmaceutical, diagnostic, or medical device industries
- Prior experience leading a Quality Assurance organization, including developing high-performing teams and talent
- Prior experience supporting aseptic pharmaceutical manufacturing operations
- In-depth knowledge of current GMPs, Quality Assurance, Quality Control, and applicable regulatory requirements and standards
- Direct experience conducting investigations and root cause analysis for pharmaceutical or medical device products
- Experience reviewing manufacturing and Quality Control validation documents and supporting validation activities in a regulated environment
- Proven experience leading Health Authority inspections and audits within a regulated manufacturing environment
Desired Qualifications
- Experience in advanced therapy platforms, including Radioligand Therapy, Cell and Gene Therapy, or other novel therapeutic technologies
- Experience with continuous improvement methodologies such as Lean, Six Sigma, or 5S and leading projects
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.