Novartis Pharmaceutical Manufacturing GmbH
Global Head Sterility Assurance(m/w/x)
Full-timeOn-siteSenior
Schaftenau
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NONovartis
Global Head Sterility Assurance(m/w/x)
Schaftenau
Full-timeOn-siteSenior
Nejo AI Summary
Global leadership of sterility assurance and aseptic quality across 20-30 manufacturing sites. Deep technical understanding of microbiology and aseptic processing required. Preparation for FDA and health authority inspections.
Requirements
- Graduate degree in Chemistry, Pharmacy, Microbiology, or related scientific discipline; Ph.D. or advanced degree preferred
- Strong pharmaceutical manufacturing experience, preferably in FDA-regulated global cGMP environment
- In-depth knowledge of US and EU cGMP requirements, including self-inspections, third-party audits, deviation and complaint management, GMP training, and SOP systems
- Deep technical understanding of microbiology, sterility assurance, and aseptic processing
- Proven people leadership, stakeholder management, negotiation, communication, and escalation skills across diverse global teams and functions
- Strong project management experience, with ability to lead complex cross-functional and global initiatives
- Fluent English communication skills, both written and spoken
Tasks
- Lead global sterility assurance and aseptic quality
- Ensure compliance with cGMP, health authority, and Novartis standards
- Oversee sterility assurance across 20-30 aseptic manufacturing sites
- Drive alignment and communication across the global aseptic network
- Prepare sites for FDA and other health authority inspections
- Support compliance with evolving GMP expectations, including EU GMP Annex 1
- Track and close quality actions and remediation plans
- Oversee aseptic operations in new production facilities and microbiology labs
- Provide microbiology expertise and manage contamination issues
- Promote best practices and consistent issue resolution
- Manage aseptic KPI trending and sterility assurance governance
- Develop and maintain expert networks and training programs
- Support quality programs and continuous improvement initiatives
Work Experience
- 10 - 15 years
Education
- Bachelor's degree
Languages
- English – Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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NONovartis
Global Head Sterility Assurance(m/w/x)
Schaftenau
Full-timeOn-siteSenior
Nejo AI Summary
Global leadership of sterility assurance and aseptic quality across 20-30 manufacturing sites. Deep technical understanding of microbiology and aseptic processing required. Preparation for FDA and health authority inspections.
Requirements
- Graduate degree in Chemistry, Pharmacy, Microbiology, or related scientific discipline; Ph.D. or advanced degree preferred
- Strong pharmaceutical manufacturing experience, preferably in FDA-regulated global cGMP environment
- In-depth knowledge of US and EU cGMP requirements, including self-inspections, third-party audits, deviation and complaint management, GMP training, and SOP systems
- Deep technical understanding of microbiology, sterility assurance, and aseptic processing
- Proven people leadership, stakeholder management, negotiation, communication, and escalation skills across diverse global teams and functions
- Strong project management experience, with ability to lead complex cross-functional and global initiatives
- Fluent English communication skills, both written and spoken
Tasks
- Lead global sterility assurance and aseptic quality
- Ensure compliance with cGMP, health authority, and Novartis standards
- Oversee sterility assurance across 20-30 aseptic manufacturing sites
- Drive alignment and communication across the global aseptic network
- Prepare sites for FDA and other health authority inspections
- Support compliance with evolving GMP expectations, including EU GMP Annex 1
- Track and close quality actions and remediation plans
- Oversee aseptic operations in new production facilities and microbiology labs
- Provide microbiology expertise and manage contamination issues
- Promote best practices and consistent issue resolution
- Manage aseptic KPI trending and sterility assurance governance
- Develop and maintain expert networks and training programs
- Support quality programs and continuous improvement initiatives
Work Experience
- 10 - 15 years
Education
- Bachelor's degree
Languages
- English – Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Novartis
Industry
Pharmaceuticals
Description
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Not a perfect match?
- Novartis Pharmaceutical Manufacturing GmbH
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