Sanofi-Aventis Deutschland GmbH
Microbiology Quality Control Manager(m/w/x)
Full-timeOn-siteSenior
Frankfurt am Main
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SASanofi-Aventis Deutschland GmbH
Quality Contamination Control Manager(m/w/x)
Frankfurt am Main
Full-timeOn-siteSenior
Nejo AI Summary
Quality leadership for biopharma contamination and microbiological control. Advanced degree and 5+ years industry experience required. Professional development and growth opportunities.
Requirements
- Advanced degree in Microbiology, Biology, Pharmacy, or equivalent
- MSc or PhD preferred
- Minimum 5 years industry experience
- Experience in biopharma, contamination control, or microbiological QC
- In-depth knowledge of biologic product licensing
- Knowledge of regulatory requirements (e.g., Annex 1)
- Knowledge of production of active substances and drug products
- Strong understanding of GMP compliance
- Strong understanding of quality systems in pharmaceutical manufacturing
- Expertise in quality risk management
- Expertise in continuous improvement methodologies
- Experience with international regulatory bodies and requirements
- Excellent leadership skills
- Excellent communication skills
- Excellent decision-making skills
- Excellent negotiation skills
- Demonstrated ability to develop team members
- Demonstrated ability to mentor team members
- Proficiency in English
- Fluency in German is a plus
Tasks
- Provide quality leadership for contamination control
- Provide quality leadership for microbiological quality control
- Oversee contamination control during design phases
- Oversee microbiological QC during design phases
- Oversee contamination control during construction C&Q
- Oversee microbiological QC during construction C&Q
- Oversee contamination control during PQ
- Oversee microbiological QC during PQ
- Oversee contamination control during Validation
- Oversee microbiological QC during Validation
- Oversee contamination control for future site organizations
- Oversee microbiological QC for future site organizations
- Endorse contamination control decisions at project level
- Participate in project strategy development
- Participate in future site strategy development
- Ensure contamination control of Sanofi-products
- Ensure microbiological QC of Sanofi-products
- Ensure compliance with regulatory requirements
- Consider new regulatory developments
- Ensure effective use of contamination control resources
- Support project plan execution
- Support commissioning activities
- Support qualification activities
- Support validation activities
- Represent project on contamination control matters
- Drive improvements for regulatory compliance
- Support optimization of manufacturing costs
- Support efficient resource use
- Support streamlined operations
- Support streamlined maintenance
- Contribute to new API facility delivery in Frankfurt
- Contribute to new API facility delivery in Beijing
- Focus on energy efficiency
- Focus on waste reduction
- Focus on digitalization
- Align with Sanofi's sustainability goals
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Native
- German – Basic
Benefits
Learning & Development
- Professional development and growth opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi-Aventis Deutschland GmbH 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.
Not a perfect match?
- Sanofi-Aventis Deutschland GmbH
Quality Lead(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Mainfrom 113,760 - 151,680 / year - Sanofi-Aventis Deutschland GmbH
Contamination Control Specialist(m/w/x)
Full-timeTemporary contractOn-siteExperiencedFrankfurt am Main - 100055 Fresenius Kabi Deutschland GmbH
Senior Manager Sterility Assurance(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Sanofi
Quality Sterility Assurance & Microbiology Manager:in(m/w/x)
Full-timeTemporary contractOn-siteJuniorFrankfurt am Main
SASanofi-Aventis Deutschland GmbH
Quality Contamination Control Manager(m/w/x)
Frankfurt am Main
Full-timeOn-siteSenior
Nejo AI Summary
Quality leadership for biopharma contamination and microbiological control. Advanced degree and 5+ years industry experience required. Professional development and growth opportunities.
Requirements
- Advanced degree in Microbiology, Biology, Pharmacy, or equivalent
- MSc or PhD preferred
- Minimum 5 years industry experience
- Experience in biopharma, contamination control, or microbiological QC
- In-depth knowledge of biologic product licensing
- Knowledge of regulatory requirements (e.g., Annex 1)
- Knowledge of production of active substances and drug products
- Strong understanding of GMP compliance
- Strong understanding of quality systems in pharmaceutical manufacturing
- Expertise in quality risk management
- Expertise in continuous improvement methodologies
- Experience with international regulatory bodies and requirements
- Excellent leadership skills
- Excellent communication skills
- Excellent decision-making skills
- Excellent negotiation skills
- Demonstrated ability to develop team members
- Demonstrated ability to mentor team members
- Proficiency in English
- Fluency in German is a plus
Tasks
- Provide quality leadership for contamination control
- Provide quality leadership for microbiological quality control
- Oversee contamination control during design phases
- Oversee microbiological QC during design phases
- Oversee contamination control during construction C&Q
- Oversee microbiological QC during construction C&Q
- Oversee contamination control during PQ
- Oversee microbiological QC during PQ
- Oversee contamination control during Validation
- Oversee microbiological QC during Validation
- Oversee contamination control for future site organizations
- Oversee microbiological QC for future site organizations
- Endorse contamination control decisions at project level
- Participate in project strategy development
- Participate in future site strategy development
- Ensure contamination control of Sanofi-products
- Ensure microbiological QC of Sanofi-products
- Ensure compliance with regulatory requirements
- Consider new regulatory developments
- Ensure effective use of contamination control resources
- Support project plan execution
- Support commissioning activities
- Support qualification activities
- Support validation activities
- Represent project on contamination control matters
- Drive improvements for regulatory compliance
- Support optimization of manufacturing costs
- Support efficient resource use
- Support streamlined operations
- Support streamlined maintenance
- Contribute to new API facility delivery in Frankfurt
- Contribute to new API facility delivery in Beijing
- Focus on energy efficiency
- Focus on waste reduction
- Focus on digitalization
- Align with Sanofi's sustainability goals
Work Experience
- 5 years
Education
- Master's degree
Languages
- English – Native
- German – Basic
Benefits
Learning & Development
- Professional development and growth opportunities
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi-Aventis Deutschland GmbH 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.
About the Company
Sanofi-Aventis Deutschland GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
Not a perfect match?
- Sanofi-Aventis Deutschland GmbH
Microbiology Quality Control Manager(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Quality Lead(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Mainfrom 113,760 - 151,680 / year - Sanofi-Aventis Deutschland GmbH
Contamination Control Specialist(m/w/x)
Full-timeTemporary contractOn-siteExperiencedFrankfurt am Main - 100055 Fresenius Kabi Deutschland GmbH
Senior Manager Sterility Assurance(m/w/x)
Full-timeOn-siteSeniorBad Homburg vor der Höhe - Sanofi
Quality Sterility Assurance & Microbiology Manager:in(m/w/x)
Full-timeTemporary contractOn-siteJuniorFrankfurt am Main