Clinical Development Quality Lead

vor 1 Woche

Lausanne, Waadt, Schweiz Coopers Group AG Vollzeit

Clinical Development Quality Lead
You will lead the implementation of the quality startegy within Clinical Development.

Responsibilities

  • Managing document & data accuracy (eCTD Module 5)
  • CRO/Vendor selection and qualification process
  • Collaborate with the Clinical Trial Manager and Study Teams
  • Compliance oversight on clinical quality
  • Reviewing clinical study documents to ensure crossdocument consistency
  • Lead / contribute to compoundspecific Regulatory Authority Inspections / Due Diligence Activities
  • Build collaborative working relationships and ensure adequate communication within the compoundspecific study team and crossfunctional Quality peers, assist in driving change to build a culture of compliance throughout the Clinical Development organization
  • Provide Audit / CAPA support

Requirements:

  • University Degree in Sciences
  • Min 6 years of experience in the clinical setting in the pharmaceutical/biotech industry
  • Min 3 years within Clinical Quality Management System & Compliance
  • Excellence knowledge of GCP and experience in managing and conducting GCP audits
  • Exoerience in QA vendors oversight
  • Fluent in English, French an asset
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