This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards across preclinical and clinical laboratory functions
Job Summary
This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards across preclinical and clinical laboratory functions.
The position involves leading inspection readiness activities, managing regulatory inspections, and resolving findings through corrective and preventive actions.
CSL is a global biotherapeutics leader committed to saving lives through innovative therapies and a diverse workforce culture.
Matching Summary
This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards across preclinical and clinical laboratory functions.
Salary
Base: $94,000 - $111,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Not specified
Skills & Requirements
Must-have
Knowledge of OECD Principles of GLP
Experience with ISO/IEC 17025 standards
Review and approval of study protocols
Management of CAPA and deviations
Conducting facility and document inspections
Nice-to-have
Strong planning and organizational skills
Commitment to continuous improvement
Excellent presentation and negotiation skills
Customer focus in R&D partnerships
Ability to model quality culture
Key Requirements
BS Degree in biological science or related discipline
Minimum 3 years experience in GLP/GxP environments
Experience in R&D Quality or product development teamwork