Sanofi-Aventis Deutschland GmbH
Microbiology Quality Control Manager(m/w/x)
Vollzeitnur vor OrtSenior
Frankfurt am Main
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
SASanofi-Aventis Deutschland GmbH
Quality Contamination Control Manager(m/w/x)
Frankfurt am Main
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality leadership for biopharma contamination and microbiological control. Advanced degree and 5+ years industry experience required. Professional development and growth opportunities.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Benefits
Weiterbildungsangebote
- Professional development and growth opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sanofi-Aventis Deutschland GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Sanofi-Aventis Deutschland GmbH
Quality Lead(m/w/x)
Vollzeitnur vor OrtSeniorFrankfurt am Mainab 113.760 - 151.680 / Jahr - Sanofi-Aventis Deutschland GmbH
Contamination Control Specialist(m/w/x)
VollzeitBefristeter Vertragnur vor OrtBerufserfahrenFrankfurt am Main - 100055 Fresenius Kabi Deutschland GmbH
Senior Manager Sterility Assurance(m/w/x)
Vollzeitnur vor OrtSeniorBad Homburg vor der Höhe - Sanofi
Quality Sterility Assurance & Microbiology Manager:in(m/w/x)
VollzeitBefristeter Vertragnur vor OrtJuniorFrankfurt am Main
SASanofi-Aventis Deutschland GmbH
Quality Contamination Control Manager(m/w/x)
Frankfurt am Main
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Quality leadership for biopharma contamination and microbiological control. Advanced degree and 5+ years industry experience required. Professional development and growth opportunities.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
Benefits
Weiterbildungsangebote
- Professional development and growth opportunities
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Sanofi-Aventis Deutschland GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Sanofi-Aventis Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
Noch nicht perfekt?
- Sanofi-Aventis Deutschland GmbH
Microbiology Quality Control Manager(m/w/x)
Vollzeitnur vor OrtSeniorFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Quality Lead(m/w/x)
Vollzeitnur vor OrtSeniorFrankfurt am Mainab 113.760 - 151.680 / Jahr - Sanofi-Aventis Deutschland GmbH
Contamination Control Specialist(m/w/x)
VollzeitBefristeter Vertragnur vor OrtBerufserfahrenFrankfurt am Main - 100055 Fresenius Kabi Deutschland GmbH
Senior Manager Sterility Assurance(m/w/x)
Vollzeitnur vor OrtSeniorBad Homburg vor der Höhe - Sanofi
Quality Sterility Assurance & Microbiology Manager:in(m/w/x)
VollzeitBefristeter Vertragnur vor OrtJuniorFrankfurt am Main