Head, Clinical Trial Qa

CSL BEHRING

**
Global clinical trial quality system
R&d quality management system
Gcp and cross functional consultancy expertise
** CSL Behring is seeking a Head of Clinical Trial Quality Assurance to oversee the global Clinical Quality Assurance function, ensuring compliance and strategic direction for clinical trials. The ideal candidate will have extensive experience in quality management systems and clinical development, with a strong leadership background. **

Job Summary

  • The Head of Clinical Trial Quality Assurance role maintain and enhance the Global Clinical Trial Quality System supporting Early to Late-stage clinical development projects within R&D.
  • This position strategically oversees aspects of the R&D Quality Management in relation to key quality elements such as Document Management, Knowledge Management, Significant Issue / Serious Breach Management, Deviation and CAPA Management, Risk Management, Continuous Improvement, Inspection Management, Change Management and R&D Quality Governance associated with R&D clinical development.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Head of Clinical Trial Quality Assurance to oversee the global Clinical Quality Assurance function, ensuring compliance and strategic direction for clinical trials. The ideal candidate will have extensive experience in quality management systems and clinical development, with a strong leadership background. **

Skills & Requirements

Must-have

  • Global Clinical Trial Quality System
  • R&D Quality Management System
  • GCP and cross functional consultancy expertise
  • Inspection management
  • Significant Issue / Serious Breach Management
  • Deviation and CAPA Management

Nice-to-have

  • High ethical standards
  • Visible and credible advocate for compliance
  • Customer focus
  • Innovative business improvements

Key Requirements

  • Undergraduate degree (BA/BS) in Scientific discipline/Life Sciences or similar
  • 10+ years’ pharmaceutical company experience
  • Previous experience with inspection management preferred
  • Experience in Pharmacovigilance/GMP/Pre-Clinical related roles is desirable
  • Strong leadership role with experience in pre-clinical/clinical regulations

Work Rights

Not specified

Tailored Resume

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