Director, Clinical Compliance

CSL Behring

King of Prussia, PA, USA
Hybrid
Global clinical quality management
Inspection readiness team leadership
Gcp practices assurance
CSL's R&D organization is accelerating innovation to deliver greater impact for patients, 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, building a future-ready team that thrives in dynamic biotech ecosystems.
  • You are responsible for leading a global clinical quality management and inspection readiness team, ensuring clinical study teams are following GCP practices.
  • The position drives Quality by Design and risk-based approaches to study design and conduct in coordination with partners responsible for implementing and overseeing clinical trials.

Matching Summary

CSL's R&D organization is accelerating innovation to deliver greater impact for patients, 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 assurance
  • Quality by Design implementation
  • Risk-based approaches to study design
  • ICH GCP Guidelines adherence

Nice-to-have

  • Agile team collaboration
  • Dynamic biotech ecosystems
  • Meaningful difference worldwide
  • Culture of curiosity and empathy

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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