Director, Clinical Compliance

CSL

King of Prussia, PA, USA
Hybrid
Global clinical quality management
Inspection readiness team leadership
Gcp practices adherence
CSL's R&D organization is accelerating innovation to deliver greater impact for patients by building a future-ready team that thrives in dynamic biotech ecosystems

Job Summary

  • CSL's R&D organization is accelerating innovation to deliver greater impact for patients by building a future-ready team that thrives in dynamic biotech ecosystems.
  • This role provides leadership and management for clinical compliance staff working to ensure that clinical study teams are following GCP practices and drives Quality by Design and risk-based approaches.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.

Matching Summary

CSL's R&D organization is accelerating innovation to deliver greater impact for patients by building a future-ready team that thrives in dynamic biotech ecosystems.

Skills & Requirements

Must-have

  • Global clinical quality management
  • Inspection readiness team leadership
  • GCP practices adherence
  • Quality by Design implementation
  • Risk-based approaches to study design
  • ICH GCP Guidelines knowledge

Nice-to-have

  • Dynamic biotech ecosystems
  • Agile team commitment
  • Culture of curiosity and empathy
  • Patient-focused innovation

Key Requirements

  • 10+ years clinical development/research experience
  • 3+ years line management experience
  • Degree in scientific/medical/pharmaceutical discipline
  • Thorough knowledge of ICH GCP, FDA GCP Regulations, EU clinical trials directive

Work Rights

Not specified

Tailored Resume

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