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Csmmh is seeking a Senior Quality Associate for Preclinical & Laboratory Quality to ensure compliance with GLP, GCLP, and other GxP requirements within their R&D functions. The role involves supporting quality initiatives, conducting inspections, and maintaining robust quality systems to enhance compliance and continuous improvement.
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Job Summary
This role ensures compliance with GLP, GCLP, and ISO/IEC 17025 standards while supporting the implementation of global quality strategies across research and development 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 offers a comprehensive compensation package including base salary, incentive compensation, and equity, alongside a strong commitment to inclusion and belonging.
Matching Summary
Match Score: 75
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Csmmh is seeking a Senior Quality Associate for Preclinical & Laboratory Quality to ensure compliance with GLP, GCLP, and other GxP requirements within their R&D functions. The role involves supporting quality initiatives, conducting inspections, and maintaining robust quality systems to enhance compliance and continuous improvement.
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Salary
Base: $94,000 - $111,000; Bonus/Equity: Incentive compensation and equity included; Benefits: Comprehensive benefits package available
Skills & Requirements
Must-have
Knowledge of OECD Principles of GLP
Experience with ISO/IEC 17025 standards
Minimum 3 years in GLP/GxP environments
Ability to manage regulatory inspections
Expertise in Quality Systems implementation
Nice-to-have
Strong planning and organizational skills
Excellent presentation and negotiation abilities
Commitment to continuous improvement culture
Customer-focused approach to stakeholder management
Experience with R&D deviation risk assessment
Key Requirements
BS Degree in biological science or related discipline
Minimum 3 years experience in GLP/GxP laboratories
Experience in R&D Quality or product development teamwork