The Head of Clinical Trial Quality Assurance role maintains and enhances the Global Clinical Trial Quality System supporting Early to Late-stage clinical development projects within R&D
Job Summary
The Head of Clinical Trial Quality Assurance role maintains and enhances the Global Clinical Trial Quality System supporting Early to Late-stage clinical development projects within R&D.
Direct, manage, and strategically improve clinical quality assurance (CQA) function globally, ensuring best use of capabilities, expertise, and harmonized processes/procedures.
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
The Head of Clinical Trial Quality Assurance role maintains and enhances the Global Clinical Trial Quality System supporting Early to Late-stage clinical development projects within R&D.
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
Strategic leadership
Continuous improvement initiatives
Global cross functional teams
Customer focus and negotiation skills
Key Requirements
Undergraduate degree in Scientific discipline/Life Sciences
10+ years pharmaceutical company experience
Previous inspection management experience
Experience in Pharmacovigilance/GMP/Pre-Clinical desirable
Strong leadership role with pre-clinical/clinical regulations knowledge