Global Head Qa Operations Aseptics

Novartis UK

Multiple Locations, United Kingdom
Aseptic drug product operations
Cell & gene therapies oversight
Cgmp compliance
Lead and supervise Quality Units in assigned sites (Aseptic Drug Product, Cell&Gene Therapies) to ensure compliance with international cGMP standards, Novartis rules, and applicable market regulatory requirements

Job Summary

  • Lead and supervise Quality Units in assigned sites (Aseptic Drug Product, Cell&Gene Therapies) to ensure compliance with international cGMP standards, Novartis rules, and applicable market regulatory requirements.
  • Provide guidance and support to Site Quality in critical quality decisions, including budget, headcounts, people, and organizational development.
  • Collaborate to achieve breakthroughs that change patients' lives by combining smart, passionate people in a community of support and inspiration.

Matching Summary

Lead and supervise Quality Units in assigned sites (Aseptic Drug Product, Cell&Gene Therapies) to ensure compliance with international cGMP standards, Novartis rules, and applicable market regulatory requirements.

Skills & Requirements

Must-have

  • Aseptic Drug Product operations
  • Cell & Gene Therapies oversight
  • cGMP compliance
  • Health authority inspections
  • Quality systems and programs

Nice-to-have

  • Organizational development
  • Operational Excellence
  • Continuous improvement initiatives
  • Cross-site harmonization

Key Requirements

  • 15 years of experience
  • Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology
  • Manufacturing of biopharmaceuticals drug products
  • Quality Assurance experience
  • Operational knowledge of aseptic processing
  • Medical device quality requirements
  • Excellent GMP knowledge
  • Fluent English

Work Rights

Not specified

Tailored Resume

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