15 years experience in biopharmaceutical manufacturing
Operational knowledge of aseptic processing
Solid experience with health authority inspections
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Novartis is seeking a Global Head of QA Operations for its aseptic drug product and cell & gene therapy sites. The role requires extensive experience in biopharmaceutical manufacturing and quality assurance, with responsibilities including ensuring compliance with international standards and leading quality initiatives.
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Job Summary
The Global Head of QA Operations leads the Quality Units across assigned sites to ensure full compliance with international cGMP standards and Novartis rules.
This role involves evaluating quality performance through KPIs, managing critical quality decisions, and overseeing preparation for health authority inspections.
Novartis offers a collaborative environment where smart, passionate people combine to achieve breakthroughs that change patients' lives.
Matching Summary
Match Score: 75
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Novartis is seeking a Global Head of QA Operations for its aseptic drug product and cell & gene therapy sites. The role requires extensive experience in biopharmaceutical manufacturing and quality assurance, with responsibilities including ensuring compliance with international standards and leading quality initiatives.
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Skills & Requirements
Must-have
15 years experience in biopharmaceutical manufacturing
Operational knowledge of aseptic processing
Solid experience with health authority inspections
Fluent English written and spoken skills
Nice-to-have
Experience with Annex 16 clarifications
Knowledge of medical device quality requirements
Ability to drive harmonisation initiatives
Key Requirements
Graduate degree in Chemistry, Pharmacy, Microbiology, or Biotechnology
15 years of experience in drug product manufacturing and QA
Operational knowledge of aseptic environments and medical devices