Head of QA Operations (Assoc Dir level)

Novartis • Indianapolis, IN

4d • Onsite

About The Position

Make a meaningful impact at the forefront of advanced cancer care. As Head of QA Operations, you will lead the Quality Assurance Operations organization supporting Novartis' Indianapolis Radioligand Therapy (RLT) Drug Product manufacturing site, providing quality oversight for production, quality control operations, and product disposition activities. This is a highly visible leadership opportunity to build and develop high-performing teams, strengthen quality culture, and partner across manufacturing, quality control, engineering, and site leadership to ensure the reliable delivery of innovative therapies to patients who need them most. If you are passionate about operational excellence, regulatory compliance, and developing people while driving continuous improvement, this role offers the opportunity to make a lasting difference every day.

Requirements

• 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 G xP 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 G MPs , 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.

Nice To Haves

• 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.

Responsibilities

• Lead the QA Operations organization, providing quality oversight for Drug Product (DP) Manufacturing and Quality Control operations, including Shop Floor QA, QA Engineering, and final product disposition.
• Ensure compliant and timely product disposition decisions while maintaining patient safety and regulatory compliance.
• Drive quality oversight across manufacturing operations, promoting inspection readiness and operational excellence.
• Lead resource allocation, capacity planning, and operational prioritization to support quality, compliance, and business objectives.
• Lead investigations, deviations, corrective actions, and change controls to resolve quality issues effectively.
• Ensure preparation, review, and delivery of validation plans supporting compliant manufacturing and quality operations.
• Support escalation management, FDA interactions, and commercial product field actions while maintaining inspection readiness.
• Build, coach, and develop high-performing leaders and teams while strengthening site quality culture.
• Partner cross-functionally to achieve production goals, address risks, and support business priorities.
• Monitor quality performance metrics and drive continuous improvement initiatives to strengthen compliance and execution.

Benefits

• health
• life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• a generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Senior