Novartis Group Companies

Head of QA Operations (Assoc Dir level)

Indianapolis

Sponsorship not specifiedDetected 2 days ago

ComplianceProcess ImprovementFDA RegulatoryCRISPRMedical DevicesResearchLeadershipCollaboration

About the role

Band Level 5 Job Description Summary Location: Indianapolis, Indiana Make a meaningful impact at the forefront of advanced cancer care.
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.

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.
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.
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.
Prior experience leading a Quality Assurance organization, including developing high-performing teams and talent.
Experience reviewing manufacturing and Quality Control validation documents and supporting validation activities in a regulated environment.

Bachelor of Science in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related experience.
Experience with continuous improvement methodologies such as Lean, Six Sigma, or 5S and leading projects.

$138,600.00 - $257,400.00
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.
role, eligibility to be considered for annual equity awards.

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.
Direct experience conducting investigations and root cause analysis for pharmaceutical or medical device products.
Proven experience leading Health Authority inspections and audits within a regulated manufacturing environment.

The Novartis Group of Companies are Equal Opportunity Employers.
We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.

This listing is sourced directly from Novartis Group Companies's careers page and normalized into a canonical job model.