• Represent CQA for clinical trials
  • Escalate serious/continuing non-compliance GxP issues as appropriate/necessary
  • Manage quality system documents (e.g., SOP, WIs)
  • Present ICH-GCP important topics (e.g., CQA audit findings, GCP inspections)
  • Organize trainings on clinical trial requirements (e.g., ICH-GCP refresher)


  • Bachelor's degree or equivalent education/degree in (life) sciences or healthcare
  • Experienced in clinical research & development
  • Good knowledge of clinical trial regulatory requirements and pharmaceutical industry practices (particularly ICH-GCP)
  • At least 6 years of experience within the pharmaceutical industry
  • Very good risk analysis and problem-solving skills