Director, Clinical Compliance

Hearthstone Sl

King of Prussia, PA, USA
Hybrid
Clinical quality management leadership
Inspection readiness for clinical trials
Quality management system (qms) implementation
CSL's R&D organization is accelerating innovation to deliver greater impact for patients in a dynamic biotech ecosystem

Job Summary

  • CSL's R&D organization is accelerating innovation to deliver greater impact for patients in a dynamic biotech ecosystem.
  • The role leads a global clinical compliance team ensuring clinical studies follow GCP practices and drives Quality by Design and risk-based approaches.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and fostering a diverse and inclusive workforce.

Matching Summary

CSL's R&D organization is accelerating innovation to deliver greater impact for patients in a dynamic biotech ecosystem.

Skills & Requirements

Must-have

  • Clinical quality management leadership
  • Inspection readiness for clinical trials
  • Quality Management System (QMS) implementation
  • GCP compliance and consultancy
  • Risk-based study design approaches
  • CAPA management in clinical development

Nice-to-have

  • Hybrid work environment
  • Collaboration with global clinical teams
  • Focus on innovation in biotech ecosystems
  • Inclusion and belonging culture

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/EU regulations

Work Rights

Not specified

Tailored Resume

Cover Letter