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, 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.
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
Significant Issue / Serious Breach Management
Deviation and CAPA Management
Nice-to-have
High ethical standards
Customer focus
Influencing and negotiation skills
Advocate for compliance and quality concepts
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