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NONovartis Pharmaceutical Manufacturing GmbH

Global Head QA Operations Aseptics(m/w/x)

Schaftenau
Full-timeOn-siteSenior
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Coordinating quality units and systems for sterile biopharmaceutical drug production across global sites. 15 years biopharmaceutical manufacturing and QA experience, with aseptic processing and GMP knowledge, required. Strategic quality leadership role with global operational scope.

Requirements

  • Graduate in Chemistry, Pharmacy, Microbiology, Biotechnology, or related science
  • 15 years experience in biopharmaceuticals drug products manufacturing and Quality Assurance
  • Operational knowledge of aseptic processing and medical device quality requirements
  • Excellent GMP knowledge and aseptic environments
  • QA/QC knowledge and solid experience with Authorities' inspections
  • Fluent English (written and spoken)

Tasks

  • Coordinate and support Quality Units
  • Implement Quality systems and programs
  • Develop Quality systems and programs
  • Monitor Quality system performance
  • Evaluate Quality performance using KPIs
  • Report Quality progress to management
  • Report Quality issues to management
  • Ensure timely follow-up on action plans
  • Prepare for health authority inspections
  • Execute health authority inspections
  • Follow up on health authority inspections
  • Identify trends for continuous quality improvement
  • Identify opportunities for continuous quality improvement
  • Support TpT and OTBA initiatives
  • Act as NOSCEE SPOC
  • Ensure alignment with global standards
  • Guide continuous organizational improvement
  • Guide continuous organizational development
  • Drive Operational Excellence
  • Achieve better financial outcomes
  • Drive harmonization initiatives across sites
  • Drive process improvement initiatives across sites
  • Act as Supply QA contact
  • Support Annex 16 clarifications
  • Manage Artwork problems
  • Implement follow-up measures for Artwork
  • Coordinate and support Supplier certification programs
  • Perform site compliance checks
  • Support general escalation processes
  • Support quality escalation processes
  • Ensure timely communication of critical quality events
  • Ensure robust resolution of critical quality events

Work Experience

  • 15 years

Education

  • Bachelor's degree

Languages

  • English – Business Fluent
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