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NONovartis Pharmaceutical Manufacturing GmbH

Global Head Sterility Assurance(m/w/x)

Schaftenau
VollzeitVor OrtSenior
Jetzt bewerben

Global oversight of sterility assurance and aseptic quality across 20-30 manufacturing sites. 10-15 years pharmaceutical industry experience, including senior leadership, required. Focus on cGMP compliance and inspection readiness for health authorities.

Anforderungen

  • Graduate degree in Chemistry, Pharmacy, Microbiology, or related scientific discipline; Ph.D. or advanced degree preferred
  • 10–15 years pharmaceutical industry experience, including senior management or leadership roles in Quality Assurance, Quality Operations, Compliance, or global/site quality functions
  • Strong experience in pharmaceutical manufacturing, preferably within FDA-regulated and global cGMP environment
  • In-depth knowledge of cGMP requirements across US and EU, 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 regulations, and Novartis standards
  • Oversee sterility assurance across 20-30 aseptic manufacturing sites
  • Drive alignment and communication across the global aseptic network
  • Ensure inspection readiness for FDA and other health authority inspections
  • Support compliance with evolving GMP expectations, including EU GMP Annex 1
  • Track and prevent repeat observations in quality actions
  • Support quality programs and aseptic project metrics
  • Develop and maintain documentation standards
  • Promote continuous improvement initiatives
  • Oversee aseptic operations in new production facilities and microbiology labs
  • Provide microbiology expertise and manage contamination issues
  • Promote best-practice sharing and consistent issue resolution
  • Manage aseptic KPI trending and sterility assurance governance
  • Develop and implement training programs for aseptic experts

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 Pharmaceutical Manufacturing 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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