QA Manager (Pharmaceutical Quality)

Location: Seoul, South Korea

Company

hirify.global is a Japan-originated global life sciences company focused exclusively on ophthalmology, developing innovative treatments and digital solutions for eye health across more than 60 countries.

What you will do

• Manage quality operations for importation, local testing, repackaging, storage, shipment, release, and distribution activities in compliance with Korean and global requirements.
• Support the implementation, maintenance, and continuous improvement of the local Quality Management System and act as deputy Quality Management Representative.
• Coordinate quality activities with Supply Chain, Regulatory Affairs, Safety Vigilance, commercial stakeholders, warehouses, distributors, transporters, laboratories, and service providers.
• Oversee product receipt, warehousing checks, local testing, batch and shipment release, repackaging controls, temperature excursions, deviations, and product quality issues.
• Act as responsible Pharmacist or Import Manager where required and maintain local product quality compliance programs.
• Manage supplier and service-provider qualification, quality agreements, change management, deviation and CAPA tracking, performance follow-up, and periodic reviews.

Requirements

• Certified pharmacist license in Korea is required.
• Fluent Korean and English communication skills are required.
• Relevant tertiary qualification and 10–12 years of experience in pharmaceutical and/or medical device quality functions.
• Experience with commercial quality operations, GDP/GDPMD, local product testing, importation, storage, release, distribution, audits, inspections, and external service-provider oversight.
• Knowledge of Korean regulatory requirements for secondary packaging, local product testing, importation, repackaging, release, storage, and distribution, including sterile, liquid, solid, and cold-chain products.
• Strong cross-functional, cross-cultural, organizational, stakeholder-management, and change-management skills in a matrix environment.

Culture & Benefits

• Work in an inclusive global environment focused on improving patient outcomes and addressing social needs related to visual impairment.
• Flexible ways of working and a commitment to a safe, inclusive physical and virtual workplace.
• Equal opportunity employment and accommodation support during the recruitment process.
• Submit the resume using the provided format template in both Korean and English.