Novartis

Novartis

Head of QA Operations (Assoc Dir level)

Indianapolis

Sponsorship not specifiedDetected 1 day 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.

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.
  • 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.

Requirements

  • 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.

Skills

  • Collaboration, Data Integrity, Decision Making, Leadership

Compensation

  • $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.

Benefits

  • 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.

Equal opportunity

  • 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.
Apply directly at Novartis →Create a free account for alerts like thisView Novartis immigration profile

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