Quality Assurance Manager/ Supplier Management Oral products - St. Gallen

Lieu: Switzerland - St Gallen

Compagnie: CSL Vifor

Niveau de Séniorité: Manager

Votre profil

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.

We are currently looking for a Quality Assurance Manager /Specialist CMO/ Supplier Management Oral Products to join our team in St Gallen. 

Main Responsibilities
  • Management of CMOs and Suppliers for the oral portfolio.
  • Processing all quality related tasks for the outsourced manufacturing and services to different contract manufacturing organizations (CMOs) for the oral portfolio (e.g. deviations, change controls, QAGs).
  • Comply with the legislation applicable to the respective activities and with CSL Vifor procedures. 
  • Handling of complaints.
  • Guarantee cGMP compliance by assuring that all products requirements are followed as agreed in the QAGs (Quality Agreements).
  • Quality representative in CSL Vifor projects at CMOs for the oral portfolio.
  • Manage and regularly evaluate data regarding the KPIs (Key Performance Indicators) established for the area.
  • Able to operate compliant with applicable internal and external Quality requirements, by also bearing the business context in mind.
  • Support achieving lean, effective, and efficient processes. 
  • Actively participate in the implementation of improvements in the department.
  • Collaboration with internal and external stakeholders.
  • Able to allocate own time and resources in a reasonable and efficient manner and in alignment with input from line manager.

Minimum Requirements
  • Bachelor/Master’s Degree in Life Sciences or related industries or working experience in Pharm. Industry
  • Minimum of 3-5 years overall experience within the pharmaceutical, biotechnology, or medical device industry
  • Experience in Quality Assurance function
  • Communication skills to negotiate and explain quality related topics with different external stakeholders and contract organizations
  • Experience in troubleshooting and problem solving
  • Good team player
  • Fluency in English
Preferred Requirements
  • Experience in lean management tools and Operational Excellence, Belt Certificate
  • Working experience in different cultures
  • Working experience in QC, Pharmaceutical/Analytical Development and/or Manufacturing
  • Audit experience
  • Other language skills as e.g., German, Portuguese, French

Conditions pour les agences de placement