Qa Manager Clinical Gcp Audits And Compliance

vor 2 Wochen

Region Zürich, Schweiz gloor & lang ag life science careers Vollzeit

Our customer is a R&D driven biopharmaceutical company located in Zurich. Focused on Immune Response diseases. Our client develops exciting new MAbs and partners with big pharma in clinical development. For further support with the growing QA activities we seek to recruit an experienced QA person, familiar with GCP audit activities. The position is defined on a temporary base and has high chance to develop into a perm role still this year.

We are looking for an independent, experienced hands-on professional, able to manage  and keep QA oversights related to GXP incl coordination of internal trainings, manage related projects andsupport cross-fct teams. On site presence up to 4 days/week required.

Your tasks:

  • Oversight for QMS Quality Management System
  • Provides Quality Oversight prior to/ during/ close-out of clinical trials
  • Leads GCP/GMP/GLP Vendor Qualifications
  • Organize and lead audits at GCP/GMP vendors
  • Coordinates the conduct of internal audits and regulatory inspections

Your profile:

  • B.Sc, M.Sc. Life Sciences
  • 3-5 years of experience in Clinical QA Operations
  • Experience in CRO and Clinical Vendor Management
  • Excellent knowledge in GCP and GMP regulations

Your autonomy, your integrity, and your initiative are of particular value. Your service-oriented approach will be of help to liaise with all internal and external stakeholders involved. Join our customer as the next reliable team member in this familial work environment. Working place is close to public transportation within Zurich area.

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