Cqa Vendor Oversight And Quality Assurance Lead (us)
csl.co.th
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Gxp quality experience with vendor oversight
Glp gcp gmp gvp regulatory adherence
Risk-based vendor qualification strategies
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CSL Behring is seeking a CQA Vendor Oversight and Quality Assurance Lead to oversee the quality management of external partners in R&D and regulated activities. The role requires a strong background in GxP quality standards, vendor lifecycle management, and cross-functional collaboration to ensure compliance and continuous improvement.
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Job Summary
This role owns the quality oversight of external partners supporting R&D and regulated activities including CROs, CMOs, and laboratories.
The position requires leading the end-to-end vendor lifecycle from due diligence and qualification to risk-based monitoring and continuous improvement.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies for immunology and hematology conditions.
Matching Summary
Match Score: 75
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CSL Behring is seeking a CQA Vendor Oversight and Quality Assurance Lead to oversee the quality management of external partners in R&D and regulated activities. The role requires a strong background in GxP quality standards, vendor lifecycle management, and cross-functional collaboration to ensure compliance and continuous improvement.
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Skills & Requirements
Must-have
GxP quality experience with vendor oversight
GLP GCP GMP GVP regulatory adherence
Risk-based vendor qualification strategies
Quality agreement negotiation and management
Inspection support and CAPA implementation
Nice-to-have
Strong analytical and problem-solving skills
Experience with multinational teams
Excellent communication and influencing skills
Knowledge of ICH guidelines and data integrity
Ability to work with limited supervision
Key Requirements
Bachelor's degree in relevant scientific discipline
3+ years of GxP quality experience
Direct vendor/CRO/CMO oversight and auditing experience
Demonstrated knowledge of ICH E6(R2)/E8(R1)/Q9(R1) guidelines