Cmo Quality Lead

vor 1 Woche

Zug, Zug, Schweiz Swisslinx Vollzeit

On behalf of our client, an international Biotechnology company based in Baar, Swisslinx is looking for a CMO Quality Lead.

This is a contract until the end of the year (extension possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.


  • Start date: March 2023
  • Duration: until the end of the year
  • Extension: possible
  • Work location: Baar
  • Workload: 100%
  • Hybrid work (remote and on site)

Your mission:

  • Manage the Quality Activities with key/preferred manufacturing and testing partners (CMOs) for assigned products/projects by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements
  • Evaluation of the performance of contractors and the identification, negotiation, implementation and followup of process and systems improvements
  • Quality management of the product lifecycle management in relation with contract manufacturing, artworks and support to asset functions such as review and approval of regulatory filings
  • Be point of contact with key/critical CMOs, establishing the appropriate relationship and is a member of the internal Virtual Plan team

Your profile:

  • Minimum Bachelor's degree, Master degree preferred, in a scientific topic (Pharmacy, Chemistry, Biology, Biochemistry etc.).
  • Minimum of 5 years of experience in pharmaceutical or biotechnology industries
  • Relevant experience in either manufacturing, development, quality or regulatory
  • Understanding of cGXPs, quality systems and regulations (FDA and EU, knowledge of Japanese or other geographies' regulations is a plus)
  • Knowledge of medical device regulations and unit operations for manufacturing of either parenterals or parmaceuticals, is a plus
  • Experience in project management and ability to develop effective working relationships with internal/external sites and crossfunctional project teams

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