This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data
Job Summary
This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data.
The position requires identifying findings and non-compliance trends that could impact the integrity of clinical research across external sites and vendors.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology and hematology.
Matching Summary
This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data.
Skills & Requirements
Must-have
Clinical audit execution experience
GCP regulations knowledge ICH E6
Risk categorization and CAPA development
Trend analysis for non-compliance
Global travel up to 50%
Nice-to-have
Excellent interpersonal negotiation skills
Collaboration with multinational teams
Support for inspection readiness activities
Continuous improvement of SOPs
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience in GCP-regulated environment
Experience in clinical audit and inspection management