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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 global Quality Units for sterile biopharmaceutical production. 15 years biopharmaceutical manufacturing QA experience required. Global coordination across multiple production sites.

Requirements

  • Graduate in Chemistry, Pharmacy, Microbiology, Biotechnology, or related science
  • 15 years experience in biopharmaceuticals 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 and develop Quality systems and programs
  • Monitor Quality system performance
  • Evaluate Quality performance using KPIs and reporting
  • Report progress and issues to QA management
  • Ensure timely follow-up on action plans
  • Prepare, execute, and follow up on health authority inspections
  • Determine trends for quality improvement
  • Identify opportunities for quality improvement
  • Support TpT and OTBA initiatives
  • Act as NOSCEE SPOC
  • Ensure alignment with global standards
  • Guide organizational improvement and development
  • Drive Operational Excellence
  • Improve 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 problems
  • Coordinate and support supplier certification programs
  • Perform site compliance checks
  • Support the site escalation process
  • 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

Tools & Technologies

  • aseptic processing
  • GMP
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Pharmaceutical Manufacturing GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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