Director, Clinical Compliance

cslbehring.cl

King of Prussia, PA, US
**
Global clinical quality management
Inspection readiness for clinical trials
Quality management system implementation
** CSL Behring is seeking a Director of Clinical Compliance to lead their global clinical quality management and inspection readiness efforts. The ideal candidate will have extensive experience in clinical development and compliance, with a focus on GCP practices, and will work in a hybrid capacity from either King of Prussia, PA, or Maidenhead, UK. **

Job Summary

  • CSL's R&D organization is accelerating innovation to deliver greater impact for patients in a dynamic biotech ecosystem.
  • The Director, Clinical Compliance leads a global team to ensure clinical studies follow GCP practices and drives quality by design and risk-based approaches.
  • CSL Behring is a global biotherapeutics leader committed to inclusion, belonging, and delivering innovative therapies worldwide.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Director of Clinical Compliance to lead their global clinical quality management and inspection readiness efforts. The ideal candidate will have extensive experience in clinical development and compliance, with a focus on GCP practices, and will work in a hybrid capacity from either King of Prussia, PA, or Maidenhead, UK. **

Skills & Requirements

Must-have

  • Global clinical quality management
  • Inspection readiness for clinical trials
  • Quality Management System implementation
  • Risk-based study design approaches
  • Clinical compliance and GCP guidance
  • CAPA management and quality investigations

Nice-to-have

  • Hybrid work environment
  • Collaboration with cross-functional teams
  • Focus on patient impact and innovation

Key Requirements

  • Degree in scientific/medical/pharmaceutical discipline
  • 10+ years clinical development experience
  • 3+ years line management experience
  • Thorough knowledge of ICH GCP and FDA GCP regulations
  • Experience in clinical trial compliance

Work Rights

Not specified

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