The Head of Clinical Trial Quality Assurance role will maintain and enhance 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 will 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, and Inspection Management.
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.
Matching Summary
The Head of Clinical Trial Quality Assurance role will maintain and enhance 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
Deviation and CAPA Management
Nice-to-have
Strategic leadership
Continuous improvement initiatives
Global cross functional teams
Customer focus and negotiation skills
Key Requirements
10+ years pharmaceutical experience
Undergraduate degree in Life Sciences
Experience with inspection management preferred
Experience in Pharmacovigilance/GMP/Pre-Clinical desirable