This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards while supporting the implementation of quality initiatives across R&D 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 functions.
The position involves leading inspection readiness activities, managing regulatory inspections, and resolving findings through corrective and preventive actions.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, offering a culture of inclusion and belonging at its core.
Matching Summary
This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards while supporting the implementation of quality initiatives across R&D functions.
Salary
Base: $94,000 - $111,000; Bonus/Equity: Incentive compensation and equity may be included; Benefits: Refer to CSL well-being documentation
Skills & Requirements
Must-have
GLP and GCLP compliance knowledge
ISO/IEC 17025 testing requirements
OECD Principles of GLP application
Regulatory inspection readiness management
CAPA and deviation control facilitation
Nice-to-have
Strong planning and organizational skills
Effective negotiation and decision-making
Commitment to continuous improvement
Customer-focused approach to quality
Global harmonized quality strategy experience
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