Senior Quality Assurance Director, Clinical Trials

3 days ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We are seeking an experienced Senior Quality Assurance Director to join our team in Copenhagen, Denmark, Utrecht, the Netherlands, or Princeton, New Jersey, U.S.

Job Summary

This is a leadership role that will be responsible for planning, conducting, and reporting quality audits within GCP regulated areas. The ideal candidate will have a strong scientific background, excellent analytical skills, and experience working in a fast-paced environment.

Main Responsibilities
  • Plan, conduct, and report on quality audits within GCP regulated areas.
  • Mentor and train QA colleagues and lead auditors to increase competency levels across the global QA GCP & PV team.
  • Develop and maintain audit strategies in collaboration with the Team Lead.
  • Coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
  • Participate in inspections and audits performed by partners.
  • Contribute to the development, maintenance, and improvement of the Genmab QMS, focusing on GCP and GCLP requirements.
  • Conduct internal GCP training and deliver advisory expertise within the company and to external vendors.
Requirements
  • MSc in Natural Science or similar, with at least 5 years of experience in GCP and GCLP.
  • Lead Auditor certification in GCP and/or GCLP, with knowledge of internal process audits and CRO audits of clinical data processing in different IT systems.
  • Practical proficiency in Veeva Vault QMS.
  • Experience with vendor qualification and due diligence processes.
  • Domain Expertise in GCP and/or GCLP, with strong communication and education skills.
Personal Qualities
  • Strong analytical skills and attention to detail.
  • Able to thrive in a complex, fast-paced environment.
  • Pro-active and open-minded, with excellent oral and written communication skills.
About You
  • You are passionate about our mission to transform patient lives through innovative cancer treatment.
  • You bring rigor and excellence to your work, believing in our science-driven approach to problem-solving.
  • You are a generous collaborator who can work effectively in teams with diverse backgrounds.
  • You are determined to do your best and take pride in enabling high-quality work from others.
  • You are not afraid to innovate and explore new ideas.
Salary Range:

$120,000 - $180,000 per year, depending on location and experience.

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