Quality Operations Manufacturing Science QC Manager

Vor 5 Tagen

St Gallen, Sankt Gallen, Schweiz CSL Vollzeit

Job Summary

We are seeking a highly skilled Quality Operations Manufacturing Science QC Manager to join our team at CSL Vifor. As a key member of our organization, you will be responsible for ensuring product knowledge and providing best support for our Contract Manufacturing Organizations (CMOs) and analytical service providers for external manufactured APIs and Finished Drug Products in the oral portfolio.

Key Responsibilities

  • Management of Quality Control / Manufacturing Science and QA activities for CMOs/suppliers of the oral portfolio
  • Ensure knowledge of manufacturing processes, QC-analytical methods, drug products, APIs and raw materials
  • SME (Subject Matter Expert) for Product Quality Risk (PQR) and Annual Product Review (APR) of external manufactured products
  • SME for Stability Studies of external manufactured products
  • Data collection, creating, review and approval of stability reports
  • Support for regulatory submissions and variations in close cooperation with global and local stakeholders
  • Creating, Review and approval of compliance records (Changes, complaints, deviation) and other documents
  • Conduct, execute and document impact assessments and investigations
  • Providing overview about Quality Performance of CMOs (CPV) and product related data
  • Support analytical method transfer to external analytical service providers/CMOs
  • Providing overview on deviations, complaints and follow-up of defined actions for improving Right First Time at CMOs
  • Performing QC-releases for Oral Products

Qualification and Experience

  • Bachelor / Master Degree in Life Sciences or related industries or working experience in pharmaceutical Industry
  • Minimum 5 years overall experience within the pharmaceutical, biotechnology, or medical device industry
  • Experience in Quality Control, Pharm. Manufacturing or Stability Management
  • Experience with software for Quality processes (e.g. Trackwise) and / or for data analysis (e.g. PowerBI, Excel, Minitab)
  • Team player
  • Fluent in English and German in an asset

Preferred Requirements

  • Working experience in different cultures
  • Working experience in Pharmaceutical/Analytical Development
  • Audit experience

About CSL Vifor

CSL Vifor is a global leader in iron deficiency and nephrology. We are a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. Our mission is to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.

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