Director, Clinical Compliance

CSL Behring

King of Prussia, PA, US
Hybrid
Clinical quality management leadership
Inspection readiness for clinical trials
Gcp compliance and guidance
CSL's R&D organization is accelerating innovation to deliver greater impact for patients and is committed to developing therapies that make a meaningful difference worldwide

Job Summary

  • CSL's R&D organization is accelerating innovation to deliver greater impact for patients and is committed to developing therapies that make a meaningful difference worldwide.
  • The Director, Clinical Compliance leads a global clinical quality management and inspection readiness team to ensure clinical study teams follow GCP practices and regulatory standards.
  • CSL Behring is a global biotherapeutics leader focused on innovative therapies and inclusion, offering a hybrid work model and a culture of curiosity and empathy.

Matching Summary

CSL's R&D organization is accelerating innovation to deliver greater impact for patients and is committed to developing therapies that make a meaningful difference worldwide.

Skills & Requirements

Must-have

  • clinical quality management leadership
  • inspection readiness for clinical trials
  • GCP compliance and guidance
  • Quality Management System implementation
  • risk-based study design approaches
  • CAPA management in clinical development

Nice-to-have

  • collaborative cross-functional partnership
  • hybrid onsite work environment
  • global clinical operations coordination

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 compliance

Work Rights

Not specified

Tailored Resume

Cover Letter