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Lead the QA Operations organization to provide quality oversight for Drug Product manufacturing and Quality Control operations. Ensure compliant product disposition and drive operational excellence and inspection readiness at the Indianapolis site.
Requires a Bachelor of Science in a scientific or engineering field and over 10 years of experience in GxP operational areas within pharma or medical devices. Must have proven experience leading QA organizations, supporting aseptic manufacturing, and managing Health Authority inspections.
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 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.
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 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.
Desirable Requirements
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.
The salary for this position is expected to range between $138,600 and $257,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary 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, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
To learn more about the culture, rewards and benefits we offer our people click here.
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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.
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 us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Find out more at https://www.novartis.com See our community guidelines: https://go.novartis.social/3Nboxki
Offices: Novartis Campus, Basel, Baselstadt 4002, CH · One Health Plaza, East Hanover, NJ 07936, US · Calle 93B S-31, Bogota, Bogota, D.C. 110541, CO · Merrion Road, Dublin, County Dublin, IE · Na Pankraci 1724/129, Prague, Prague 140 00, CZ
