12+ years pharmaceutical or medical device experience
3 years auditing experience preferred
Strong knowledge of gmp regulations
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Novartis is seeking a Global GMP Senior Quality Auditor to conduct independent GMP audits and ensure compliance with regulations and standards across manufacturing sites and suppliers. The role requires strong auditing experience, particularly in the pharmaceutical or medical device industry, and involves significant travel (up to 60%).
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Job Summary
This role requires leading complex GMP audits for sterile API, aseptic DP, and combination products while ensuring alignment with Novartis strategic direction.
The successful candidate will mentor junior staff, provide regulatory guidance for remediation, and ensure timely reporting of critical findings to management.
Novartis offers a mission-driven environment focused on reimaging medicine to improve and extend people's lives with comprehensive benefits and rewards.
Matching Summary
Match Score: 75
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Novartis is seeking a Global GMP Senior Quality Auditor to conduct independent GMP audits and ensure compliance with regulations and standards across manufacturing sites and suppliers. The role requires strong auditing experience, particularly in the pharmaceutical or medical device industry, and involves significant travel (up to 60%).
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Skills & Requirements
Must-have
12+ years pharmaceutical or medical device experience
3 years auditing experience preferred
Strong knowledge of GMP regulations
Experience in Sterile API or aseptic DP
Ability to travel up to 60% of time
Nice-to-have
Experience interacting with local Health Authorities
Fluency in languages other than English
Mentoring junior GMP staff capabilities
Diplomacy and persuasion skills
Key Requirements
12+ years broad experience in Pharmaceutical or Medical Device Industry
3 years auditing experience preferred
Solid operational experience in QA/QC management or manufacturing