QA Manager

Job Description

What you will do

• Manage day-to-day quality operations for Santen Korea to ensure compliant execution of importation, local testing, repackaging, storage, shipment/release and distribution activities in accordance with Korean regulatory requirements and Santen global requirements.
• Act as local quality operations manager and deputy Quality Management Representative, supporting the implementation, maintenance and continuous improvement of a practical and effective local Quality Management System (QMS).
• Lead quality operations topics across the local business by coordinating with Supply Chain, Regulatory Affairs, Safety Vigilance, commercial stakeholders, warehouses, distributors, transporters, testing laboratories and other service providers.
• Perform and oversee operational QA/QC activities, including product receipt, warehousing checks, local testing coordination, batch/shipment release support, repackaging controls, temperature excursion assessment, deviation handling and product quality issue resolution.
• Act as responsible Pharmacist / Import Manager where required, ensuring import and wholesale activities are supported by appropriate quality checks, records and follow-up actions.
• Maintain the local product quality compliance program for products marketed by Santen Korea, including oversight of local product testing, secondary packaging, storage, distribution and post-market quality activities.
• Manage local supplier and service provider quality oversight, including qualification, quality agreements, performance follow-up, change management, deviation/CAPA tracking and periodic review where applicable.
• Plan, coordinate and execute internal audits, supplier/service provider audits, regulatory inspections and certification audits in Korea, ensuring timely preparation, response, CAPA follow-up and inspection readiness.
• Provide quality input and operational QA support for business projects, new product introductions, product launches, product variations, supply continuity matters and other local quality initiatives.
• Monitor quality risks, compliance gaps and operational issues; propose practical solutions, escalate significant risks to senior QA management and follow through on agreed actions to closure.
• Provide managerial oversight of assigned quality operations activities through planning, prioritization, stakeholder coordination, progress tracking and issue escalation, without direct line management of staff.
• Representing Korea QA in relevant Asia or global quality discussions where local operational input is required, ensuring Korea-specific requirements and risks are appropriately communicated.

Qualifications

What you will bring to the role

• Bachelor's degree in Science or related field and licensed Pharmacist in Korea.
• 10-12+ years of experience in pharmaceutical and/or medical device quality, with strong expertise in quality operations, GDP/GDPMD, importation, local testing, storage, release, and distribution.
• Proven experience in developing, implementing, and maintaining Quality Management Systems (QMS) compliant with Korean regulatory requirements and global quality standards.
• Extensive experience working with regulatory authorities, distributors, testing laboratories, and service providers, including resolution of product quality and compliance issues.
• Strong knowledge of pharmaceutical and medical device quality requirements, including cGMP, GDP, PIC/S, ICH, ISO standards, cold chain operations, and product repackaging activities.
• Demonstrated experience managing supplier/service provider oversight, quality agreements, audits, inspections, deviations, CAPAs, change controls, and compliance programs.
• Ability to lead cross-functional quality activities, manage complex projects, identify and escalate compliance risks, and deliver results in a matrix organization.
• Excellent stakeholder management, communication, negotiation, and relationship-building skills, with fluency in Korean and English and the ability to work effectively in a global, multicultural environment.

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)