Head, Clinical Trial Qa

Cslbehring Com Au

Global clinical trial quality system
R&d quality management system
Gcp and cross functional consultancy
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, utilizing and improving the existing R&D Quality Management System in alignment with CSL overarching Quality Management System administered and managed by Global Quality

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, utilizing and improving the existing R&D Quality Management System in alignment with CSL overarching Quality Management System administered and managed by Global Quality.
  • The role manages a Global Clinical quality department supporting early and late-stage clinical trials for all CSL business units across all R&D anchor sites.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives.

Matching 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, utilizing and improving the existing R&D Quality Management System in alignment with CSL overarching Quality Management System administered and managed by Global Quality.

Skills & Requirements

Must-have

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

Nice-to-have

  • High ethical standards
  • Analytical and logical thinking
  • Customer focus
  • Influencing and negotiation skills

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
  • Experience in pre-clinical/clinical regulations

Work Rights

Not specified

Tailored Resume

Cover Letter