This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards while supporting the implementation of quality initiatives across R&D preclinical and clinical lab functions
Job Summary
This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards while supporting the implementation of quality initiatives across R&D preclinical and clinical lab functions.
The successful candidate will lead inspection readiness activities, manage regulatory inspections, and oversee corrective and preventive actions to ensure timely resolution of findings.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, offering a culture of inclusion and belonging that fuels innovation day in and day out.
Matching Summary
This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards while supporting the implementation of quality initiatives across R&D preclinical and clinical lab functions.
Salary
Base: $94,000 - $111,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Refer to CSL benefits page for details on well-being support
Skills & Requirements
Must-have
Knowledge of OECD Principles of GLP
Experience with ISO/IEC 17025 standards
Review and approve study protocols
Manage regulatory inspection readiness
Conduct facility and document inspections
Nice-to-have
Strong planning and organizational skills
Commitment to continuous improvement
Excellent negotiation and decision-making
Customer focus in R&D partnerships
Key Requirements
BS Degree in biological science or related discipline
Minimum 3 years experience in GLP/GxP laboratories or QA
Experience in R&D Quality or product development teamwork