Quality Manager
Core
Establishing, maintaining, and implementing the Quality Management System (QMS) for Pfizer's Country Offices in Korea to ensure compliance with regulatory authorities and internal standards for imported medicinal products.
Role type
Quality Manager (Responsible Person/Pharmacist)
Builds
Compliant import, distribution, and supply operations for pharmaceutical products in Korea
Domain
Pharmaceutical industry, regulatory compliance, quality assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GDP/GLP/GSP/QMS expertise, regulatory compliance (MFDS/KGMP), deviation management, CAPA management, supplier qualification, change control, risk management, technical writing, stakeholder influence
Preferred skills
Experience with enterprise systems (PDM, Quality Tracking System, Documentum), AI tool usage (ChatGPT, Copilot), leadership
Technologies
PDM, Quality Tracking System, Documentum
Responsibilities
Act as designated Responsible Person (RP) for imported medicinal products; authorize market release of imported products; manage quarantine alerts and recall operations; lead Quality Management Review (QMR) process; oversee supplier and logistics partner management; conduct self-inspections; manage deviations and complaints; implement training programs.
Seniority
Senior, hands-on IC