Director, Quality Assurance

Job Description Summary

Location: Indianapolis, Indiana


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.

Job Description

Key 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 andtimelyproduct disposition decisions whilemaintainingpatient safety and regulatory compliance.

• Drive quality oversight across manufacturing operations, promotinginspectionreadiness and operational excellence.

• Lead resource allocation, capacity planning, and operational prioritization to support quality, compliance, and businessobjectives.

• 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 whilemaintaininginspectionreadiness.

• Build, coach, and develop high-performing leaders and teams while strengthening site quality culture.

• Partner cross-functionallyto achieve production goals, address risks, and support business priorities.

• Monitor quality performance metrics and drive continuous improvement initiatives to strengthen compliance and execution.

Essential 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 operationalGxParea(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.

Desirable Requirements

• Experienceinadvancedtherapy 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 leadingprojects.

The salary for this position is expected to range between $138,600and $257,400per year.The final salary offered isdeterminedbased on factors like, but not limited to, relevant skills andexperience, and upon joiningNovartiswill be reviewed periodically. Novartis may change the publishedsalary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the

role, eligibility to be considered for annual equity awards.US-based eligible employees will receive a comprehensive benefits package that includes health,lifeanddisability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Inaddition, employees are eligible for a generous time off package including vacation, personal days,holidaysand other leaves.

To learn more about the culture, rewards and benefits we offer our people clickhere.

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to View email address on click.appcast.io or call View phone number on click.appcast.io and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$138,600.00 - $257,400.00

Skills Desired

Collaboration, Data Integrity, Decision Making, Leadership