Quality Manager
Hybrid · Seoul, Seoul, South Korea
Job Summary
Quality Manager responsible for establishing and maintaining the Quality Management System (QMS) at Pfizer Korea Country Offices to ensure MFDS, KGMP, and GDP compliance with Pfizer quality standards. Acts as the designated Responsible Person for imported medicinal products, oversees quality review and market release, disposition of returns, recalls and quarantines, coordinates AQRT/eSQRT activities, liaises with local health authorities, ensures implementation of local quality systems and training, manages CAPA and APR processes, conducts self-inspections, and leads continuous quality-improvement initiatives across supplier and logistics partner management. Requires BA/BS in pharmacy with Korean Pharmacist License, 7+ years in quality roles, and strong leadership, communication, and regulatory experience. Work location is Hybrid in Korea (Seoul).
Required Qualifications
- BA/BS with Pharmacy degree
- Korean Pharmacist License
- Minimum 7 years in pharmaceutical quality role
- Experience in GMP, GDP, GLP, GSP and QMS
- Technical writing and reporting
- Leadership and cross-functional collaboration
- Fluent in English and Korean
- Proficiency with MS Office and quality-tracking/Documentum-like systems
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