Novartis Pharmaceutical Manufacturing GmbH
Global Head Sterility Assurance(m/w/x)
Vollzeitnur vor OrtSenior
Schaftenau
Neuer Job?Nejo!
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NONovartis
Global Head Sterility Assurance(m/w/x)
Schaftenau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 - 15 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis 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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Global Head Sterility Assurance(m/w/x)
Schaftenau
VollzeitVor OrtSenior
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Berufserfahrung
- 10 - 15 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – fließend
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Novartis 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.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Novartis
Branche
Pharmaceuticals
Beschreibung
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Noch nicht perfekt?
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