Quality Assurance Manager

Category: Quality

Location:Seoul, Seoul, KR

• Act as the local Qualified Person (Registered Pharmacist, Quality Responsible Person) responsible for GDP in accordance with market regulatory requirements.
• Conduct GDP/GIP and local regulations impact assessments and implementation.
• Maintain Quality System Documentation, including procedures and records.
• Implement Deviation & CAPA management, Change control management, Self-inspection, complaint management, GDP training management, APR, and other general quality system management.

• Ensure product quality through batch release or approval to the market.
• Oversee supplier management, including Quality Agreements and approving local subcontracted activities impacting product quality.
• Evaluate and confirm supplier qualification status.
• Manage local QC testing, Co A review, and local product release when applicable.
• Coordinate and approve analytical method transfers to meet product launches when applicable.
• Handle compliance/quality events with the impacted market team.
• Coordinate and promptly perform market actions, including recalls and mock recalls for medicinal products.
• Support the Supply Chain and manage local redressing if required.

• Oversee warehouse management.
• Manage transportation processes.
• Supervise third-party laboratories.

• Maintain the Import license with the LHA.
• Support Global Quality Audits in the market.
• Prepare for and lead HA inspections in the local entity.
• Monitor external requirements.

• Pharmacist certification is mandatory
• 10-15 years of progressive experience within the quality function of the pharmaceutical industry or with regulatory agencies
• Minimum 2-3 years of people management experience
• Knowledge and experience in pharmaceutical operations, quality control, distribution and international regulations are essential and Global MNC / Matrix Organization experience is a plus
• Good knowledge of QA processes, SOPs, and Compliance guidelines, including proficiency in GDPs and the requirements for pharmaceutical products distribution
• Strong interpersonal and communication skills with supportive, persuasive, passionate and energetic mindset
• English fluency is preferred