Not specified (potentially hybrid or fully remote based on industry standards).
Global clinical trial quality system
R&d quality management system
Gcp and cross functional consultancy
The Head of Clinical Trial Quality Assurance at CSL Behring is responsible for maintaining and enhancing the Global Clinical Trial Quality System, overseeing quality assurance for early to late-stage clinical development projects. The role requires significant experience in quality management and leadership within the pharmaceutical industry, focusing on compliance and strategic direction
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.
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.
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
Match Score: 85
The Head of Clinical Trial Quality Assurance at CSL Behring is responsible for maintaining and enhancing the Global Clinical Trial Quality System, overseeing quality assurance for early to late-stage clinical development projects. The role requires significant experience in quality management and leadership within the pharmaceutical industry, focusing on compliance and strategic direction.
Skills & Requirements
Must-have
Global Clinical Trial Quality System
R&D Quality Management System
GCP and cross functional consultancy
Inspection management strategy
GxP significant quality issues management
Global workforce planning
Nice-to-have
High ethical standards
Customer focus
Advocate for compliance and quality concepts
Innovative business improvements
Mentoring and coaching staff
Key Requirements
Undergraduate degree in Scientific discipline/Life Sciences
10+ years pharmaceutical company experience
Previous experience with inspection management
Experience in Pharmacovigilance/GMP/Pre-Clinical related roles desirable