Assistant QC Operations Manager (1 Year Contract)

About the role

Santen Korea, a life sciences company focused on ophthalmology, is looking for an Assistant QC Operations Manager on a 1-year contract in Seoul. The role ensures the quality, compliance and integrity of Santen products across importation, testing, storage, release and distribution in Korea, overseeing local quality systems and operations while collaborating with laboratories and logistics providers.

Key responsibilities

• Manage quality operations for imported products, including receiving inspections, shipment release approval, import documentation and defect investigations.
• Coordinate product testing with approved contract laboratories, ensuring timely execution and accurate documentation.
• Oversee warehouse, storage and distribution quality activities, including GDP/GSP compliance, environmental monitoring, inventory handling and product disposition.
• Maintain and improve the local Quality Management System (QMS), including SOPs, training, deviations, CAPAs, change controls, risk assessments, quality metrics and product quality reviews.
• Provide quality oversight of suppliers, distributors, third-party logistics providers and contract laboratories, including quality agreements and compliance monitoring.
• Support regulatory inspections, audits, pharmacist surveillance and post-market quality initiatives, keeping inspection readiness high.
• Partner with cross-functional teams on new product launches, technology transfers, lifecycle changes and continuous improvement projects.

Required profile

• Bachelor's degree in Pharmacy or a related scientific discipline.
• Certified pharmacist license in Korea.
• Fluent Korean is a must; English is preferred.
• QA/QC experience in the pharmaceutical and/or medical device industry, including GMP manufacturing and/or commercial quality operations, is preferred.

Required skills

• Knowledge of local regulatory requirements, GMP/GDP/GSP standards and QMS for imported healthcare products is preferred.
• Experience managing quality oversight of suppliers, distributors, 3PLs, contract manufacturers and external laboratories is preferred.
• Knowledge of PIC/S, ICH, ISO standards, cold chain management, analytical method transfer and import/wholesale operations is an advantage.