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Online Laboratory Magazine
02/26/2021

Global Head - Quality Assurance GCP (m/f/d)


  • University degree in Science, Engineering or a medical field, together with 7+ years of experience in a global GCP organization in a biotech or pharmaceutical company
  • Experience in establishing and maintaining a global GCP quality system and units
  • Profound knowledge of current GCP regulations and best practices, as well as experience in FDA and EMA inspections
  • Experience with global late stage clinical trials leading to market authorization
  • Optimize a QA unit in order to support the organization in late stage clinical trials and market authorization
  • Set global GCP goals and monitor the progress
  • Lead and extend a local GCP QA team to become a global team and assure their optimal execution of GCP QA guidelines
  • Collaborate with internal and external stakeholders to achieve GCP QA objectives
  • Align with the GMP quality lead on quality systems
  • Organize and host inspections by GCP authorities


» Job description


Employer:
BioNTech AG
Location:
55131 Mainz