Director, Clinical Compliance

CSL

King of Prussia, PA, USA
Hybrid
Global clinical quality management
Inspection readiness team leadership
Gcp practices adherence
You are responsible for leading a global clinical quality management and inspection readiness team

Job Summary

  • You are responsible for leading a global clinical quality management and inspection readiness team.
  • This role provides leadership and management for clinical compliance staff working to ensure that 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

You are responsible for leading a global clinical quality management and inspection readiness team.

Skills & Requirements

Must-have

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

Nice-to-have

  • Agile team collaboration
  • Dynamic biotech ecosystems
  • Patient-focused innovation
  • Inclusion and Belonging culture

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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