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
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
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.
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 advocate
Global cross functional teams
Customer focus 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
Strong leadership role with experience in pre-clinical/clinical regulations