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NONovartis Pharmaceutical Manufacturing GmbH

Global Head Sterility Assurance(m/w/x)

Schaftenau
Full-timeOn-siteSenior
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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.

Requirements

  • 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

Tasks

  • 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

Work Experience

  • 10 - 15 years

Education

  • Bachelor's degree

Languages

  • English – Fluent
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