Director, Clinical Compliance

cslbehring.cz

King of Prussia, PA, US
Hybrid (onsite three days a week)
Clinical quality management leadership
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 team. The role requires extensive experience in clinical research and compliance, with responsibilities including the development of processes to ensure inspection readiness and adherence to regulatory standards

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 study teams follow GCP practices and drives inspection readiness.
  • CSL Behring is a global biotherapeutics leader committed to inclusion, belonging, and developing innovative therapies to save lives worldwide.

Matching Summary

Match Score: 85

CSL Behring is seeking a Director of Clinical Compliance to lead their global clinical quality management and inspection readiness team. The role requires extensive experience in clinical research and compliance, with responsibilities including the development of processes to ensure inspection readiness and adherence to regulatory standards.

Skills & Requirements

Must-have

  • Clinical quality management leadership
  • Inspection readiness for clinical trials
  • Quality Management System implementation
  • Risk-based study design approaches
  • CAPA management in clinical development
  • Compliance with ICH GCP guidelines

Nice-to-have

  • Hybrid onsite work environment
  • Collaboration with global quality assurance
  • Integration into Study Execution Teams
  • Driving Quality by Design principles
  • Support during regulatory inspections

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 regulations
  • Experience in clinical trial compliance

Work Rights

Not specified

Tailored Resume

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