[KOREA] Assistant QC Operations Manager

Job Description

What you will do

• Manage quality operations for imported products, including receiving inspections, shipment release approval, import documentation, and defect investigation activities in compliance with local regulations and company standards.

• Coordinate product testing with approved contract laboratories, ensuring timely execution, accurate documentation, and compliance with established quality requirements and specifications.

• Oversee warehouse, storage, and distribution quality activities, including GDP/GSP compliance, environmental monitoring, inventory handling, and product disposition processes.

• Maintain and continuously improve the local Quality Management System (QMS), including SOP management, training, deviations, CAPAs, change controls, risk assessments, quality metrics, and product quality reviews.

• Provide quality oversight of suppliers, distributors, third-party logistics providers (3PLs), and contract laboratories, ensuring effective quality agreements, compliance monitoring, and risk management.

• Support regulatory inspections, audits, pharmacist surveillance activities, and post-market quality initiatives by maintaining inspection readiness and driving timely closure of quality actions.

• Partner with cross-functional teams to support new product launches, technology transfers, product lifecycle changes, continuous improvement initiatives, and other business projects requiring QA/QC expertise.

Qualifications

What you will bring to the role

• Bachelor's degree in Pharmacy or a related scientific discipline; licensed pharmacist qualification preferred in accordance with local regulatory requirements.
• Minimum 8 years of QA/QC experience in the pharmaceutical and/or medical device industry, including GMP manufacturing and/or commercial quality operations.
• Strong knowledge of local regulatory requirements, GMP/GDP/GSP standards, and Quality Management Systems (QMS) for imported healthcare products.
• Experience managing quality oversight of suppliers, distributors, third-party logistics providers (3PLs), contract manufacturers, and external laboratories.
• Proven track record supporting regulatory inspections, audits, pharmacist surveillance activities, and compliance-related initiatives.
• Knowledge of PIC/S, ICH, ISO standards, cold chain management, analytical method transfer, and import/wholesale operations is an advantage.
• Excellent communication and stakeholder management skills, with fluency in both Korean and English and the ability to collaborate effectively across functions and cultures.
• Strong problem-solving, project management, and organizational skills, with the ability to manage complex priorities, drive continuous improvement, and travel as required to support quality operations and audits.

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.

Please use the attached Resume Format template when you submit the resume.

Submit in 2 languages please. (Korean & English or Korean)