This role is responsible for executing the global RDQ audit program to ensure accuracy and quality of scientific data within GxP disciplines
Job Summary
This role is responsible for executing the global RDQ audit program to ensure accuracy and quality of scientific data within GxP disciplines.
The auditor will conduct external audits of clinical sites, vendors, and databases while collaborating with QA staff on outcome categorization and escalations.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology, hematology, and other therapeutic areas.
Matching Summary
This role is responsible for executing the global RDQ audit program to ensure accuracy and quality of scientific data within GxP disciplines.
Skills & Requirements
Must-have
Global RDQ audit program execution
External clinical investigator site audits
GxP regulatory compliance knowledge
Audit report drafting and CAPA recommendations
Risk-based approach to inspections
Nice-to-have
Experience with multinational teams
Continuous improvement initiative support
Strong negotiation and influencing skills
Knowledge of QMS implementation
Ability to work with limited supervision
Key Requirements
BS degree in biological science or related discipline
3+ years of Quality Assurance experience in GVP/GCP environment
Demonstrated knowledge of regulatory frameworks and QMS
Experience in audit/inspection management processes