The Assistant QC Operations Manager is responsible for ensuring the quality, compliance, and integrity of Santen products throughout importation, testing, storage, release, and distribution activities in Korea. This role oversees local quality systems and quality operations, collaborates with internal and external partners including laboratories and logistics providers, supports regulatory inspections and audits, and ensures all activities are conducted in accordance with local regulatory requirements and Santen's global quality standards to maintain product quality and patient safety.
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.
What you will bring to the role
- Bachelor's degree in Pharmacy or a related scientific discipline
- Must hold a certified pharmacist license in Korea.
- Language proficiency in Korean is a must.
- Language proficiency in English is preferred.
- QA/QC experience in the pharmaceutical and/or medical device industry, including GMP manufacturing and/or commercial quality operations is preferred.
- Strong knowledge of local regulatory requirements, GMP/GDP/GSP standards, and Quality Management Systems (QMS) for imported healthcare products is preferred.
- Experience managing quality oversight of suppliers, distributors, third-party logistics providers (3PLs), contract manufacturers, and external laboratories preferred.
- Proven track record supporting regulatory inspections, audits, pharmacist surveillance activities, and compliance-related initiatives is preferred.
- Knowledge of PIC/S, ICH, ISO standards, cold chain management, analytical method transfer, and import/wholesale operations is an advantage is preferred.
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)