23h ago

Associate Director, Qualified Person, Europe

Amsterdam, Netherlands

โœจ $150k-$200k / yearest.

full-timesenior Remotebiotech

๐Ÿ’ผ About This Role

You'll serve as the legally registered Qualified Person (QP) for a late-stage clinical oncology company, holding ultimate responsibility for batch certification and release of medicinal products in Europe. You'll provide strategic quality leadership across the site and ensure regulatory compliance with EU GMP. This role offers the chance to lead interactions with health authorities and drive quality culture in a growing biotech.

๐ŸŽฏ What You'll Do

  • Certify and release clinical and commercial medicinal products in compliance with EU GMP.
  • Oversee deviations, CAPAs, change controls, investigations, and recalls.
  • Lead quality risk assessments and represent site during inspections.
  • Mentor QA professionals and support QP succession planning.

๐Ÿ“‹ Requirements

  • Master's degree in Pharmacy, Chemistry, Biotechnology, or relevant scientific discipline.
  • 9+ years of experience in quality roles with increasing responsibility.
  • Eligibility for registration as a Qualified Person under Dutch legislation.
  • Deep working knowledge of EU GMP and relevant regulatory frameworks.

โœจ Nice to Have

  • Dutch language skills.
  • Experience with IMP batch release under EU Clinical Trial Regulation.
  • Inspection experience with health authorities.

๐ŸŽ Benefits & Perks

  • ๐Ÿ’Š Competitive compensation including equity.
  • ๐Ÿฅ Comprehensive health insurance coverage.
  • ๐ŸŒ Remote work flexibility within the Netherlands.
  • ๐Ÿš€ Career growth in a late-stage biotech company.

๐Ÿ“จ Hiring Process

Estimated timeline: 2-4 weeks ยท AI estimate

  1. 1Recruiter Screenยท 30 min
  2. 2Hiring Manager Interviewยท 60 min
  3. 3Panel Interviewยท 90 min
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