QA Manager (Licensed Pharmacist)
Core
Serve as the designated Responsible Pharmacist for imported pharmaceuticals in Korea, ensuring regulatory compliance and leading quality systems, batch release, and supplier oversight.
Role type
Manager, Quality Assurance (Licensed Pharmacist)
Builds
Import testing results, batch releases, and compliant supply of pharmaceutical/medical device products to the Korean market.
Domain
Pharmaceuticals and Medical Devices in Korea
Required skills
Regulatory compliance (MFDS, GMP, GDP), batch release management, supplier quality oversight, deviation/CAPA management, recall management, audit leadership, risk assessment
Preferred skills
None stated
Technologies
None stated
Responsibilities
Serve as Responsible Pharmacist for imported products; oversee deviations, investigations, CAPAs, and change controls; own batch disposition and import testing approval; lead government and third-party audits; manage recalls and regulatory reporting; qualify manufacturers and distributors.
Seniority
Manager, strategic leadership & operational oversight