Sanofi-Aventis Deutschland GmbH
Quality Contamination Control Manager(m/w/x)
Vollzeitnur vor OrtSenior
Frankfurt am Main
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
SASanofi-Aventis Deutschland GmbH
Quality Lead(m/w/x)
Frankfurt am Main
ab 113.760 - 151.680 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading Quality Assurance for IFF project, ensuring GMP and BLA compliance. PhD-level qualification in Science strongly preferred. Company employee benefit programs.
Anforderungen
- Degree in Science, Pharmacy, or equivalent
- PhD-level qualification in Science strongly preferred
- Several years of industry experience in biopharma or related regulated industry
- Relevant experience in leadership quality positions
- Demonstrated leadership experience in quality role for capital investment program in PharmaBiotech
- In-depth knowledge of biologic product license application processes and regulatory requirements (FDA, Annex I, BLA)
- Strong understanding of pharmaceutical manufacturing processes, particularly large-scale biologics plants for bacterial processes
- Effective coaching skills for people development and performance improvement
- Visionary leadership to inspire quality culture across large, cross-functional teams
- Excellent communication and business partnering capabilities
- Expertise in Quality Risk Management, Quality Systems, and continuous improvement methodologies
- Strong interpersonal skills for multicultural, international environment
- Fluency in English required
- German and/or French highly advantageous
Aufgaben
- Lead Quality Assurance functions for IFF project
- Ensure compliance with Sanofi standards, GMP, BLA, and Annex I
- Develop and implement C&Q&V strategies and plans
- Manage DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols
- Prepare final CQ reports and Validation Master Plan
- Serve as Quality focal point in Frankfurt
- Integrate quality requirements with Frankfurt Bio Campus
- Drive quality culture and GMP compliance performance
- Promote continuous improvement across all functions
- Manage proactive and reactive Quality Risk Management
- Represent project as primary quality escalation point
- Operate Quality Assurance, Quality Control, and Quality Systems
- Support Qualified Persons and Regulatory Affairs
- Develop and mentor IFF Quality team
- Manage IFF quality budget and schedule
- Optimize cost and schedule decisions
- Develop synergies with Frankfurt Bio Campus and Insulin Facility Beijing
- Contribute to digital transformation strategy
- Implement MES, batch review by exception, and SMART factory initiatives
- Communicate and escalate quality issues effectively
- Update and promote Sanofi Global Quality Documentation
- Maintain IFF GOPs and global procedures
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Benefits
Mitarbeiterrabatte
- Company employee benefit programs
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.
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SASanofi-Aventis Deutschland GmbH
Quality Lead(m/w/x)
Frankfurt am Main
ab 113.760 - 151.680 / Jahr
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
Leading Quality Assurance for IFF project, ensuring GMP and BLA compliance. PhD-level qualification in Science strongly preferred. Company employee benefit programs.
Anforderungen
- Degree in Science, Pharmacy, or equivalent
- PhD-level qualification in Science strongly preferred
- Several years of industry experience in biopharma or related regulated industry
- Relevant experience in leadership quality positions
- Demonstrated leadership experience in quality role for capital investment program in PharmaBiotech
- In-depth knowledge of biologic product license application processes and regulatory requirements (FDA, Annex I, BLA)
- Strong understanding of pharmaceutical manufacturing processes, particularly large-scale biologics plants for bacterial processes
- Effective coaching skills for people development and performance improvement
- Visionary leadership to inspire quality culture across large, cross-functional teams
- Excellent communication and business partnering capabilities
- Expertise in Quality Risk Management, Quality Systems, and continuous improvement methodologies
- Strong interpersonal skills for multicultural, international environment
- Fluency in English required
- German and/or French highly advantageous
Aufgaben
- Lead Quality Assurance functions for IFF project
- Ensure compliance with Sanofi standards, GMP, BLA, and Annex I
- Develop and implement C&Q&V strategies and plans
- Manage DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols
- Prepare final CQ reports and Validation Master Plan
- Serve as Quality focal point in Frankfurt
- Integrate quality requirements with Frankfurt Bio Campus
- Drive quality culture and GMP compliance performance
- Promote continuous improvement across all functions
- Manage proactive and reactive Quality Risk Management
- Represent project as primary quality escalation point
- Operate Quality Assurance, Quality Control, and Quality Systems
- Support Qualified Persons and Regulatory Affairs
- Develop and mentor IFF Quality team
- Manage IFF quality budget and schedule
- Optimize cost and schedule decisions
- Develop synergies with Frankfurt Bio Campus and Insulin Facility Beijing
- Contribute to digital transformation strategy
- Implement MES, batch review by exception, and SMART factory initiatives
- Communicate and escalate quality issues effectively
- Update and promote Sanofi Global Quality Documentation
- Maintain IFF GOPs and global procedures
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
- Deutsch – Grundkenntnisse
- Französisch – Grundkenntnisse
Benefits
Mitarbeiterrabatte
- Company employee benefit programs
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
Quality Contamination Control Manager(m/w/x)
Vollzeitnur vor OrtSeniorFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Product Lead NLP(m/w/x)
VollzeitBefristeter Vertragnur vor OrtSeniorFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Qualified Person / Batch Release Lead(m/w/x)
Vollzeitnur vor OrtBerufserfahrenFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Laboratory Head non-GMP PP Tech Area(m/w/x)
Vollzeitnur vor OrtSeniorFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Quality Assurance Specialist(m/w/x)
VollzeitBefristeter Vertragnur vor OrtBerufserfahrenFrankfurt am Main