[KOREA] QA Manager

Company Description

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 

As an affiliate of Santen Global, guided by our vision of “Happiness with Vision,” Santen Korea is committed to improving patients' lives through innovative eye care solutions, scientific excellence, and strong partnerships with healthcare professionals.

As we continue to expand our business, we are seeking a dedicated, passionate, and talented QA Manager to join our team in Korea.

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

 

Education and Experience Requirements

• Successful completion of relevant tertiary qualification – Science Degree and is a certified pharmacist in Korea.
• Minimum 10–12 years’ experience in pharmaceutical and/or medical device quality functions, including relevant experience in commercial quality operations, GDP/GDPMD, local product testing, importation, storage, release and distribution activities.
• Experience managing quality operations, cross-functional quality activities, audits, inspections and external service provider oversight in a matrix environment.
• Excellent knowledge and experience working in Korea with vast experience on development, implementation and maintenance of a Quality Management System compliant to regulatory requirements on Good Distribution Practice (GDP) or Good Distribution Practice for Medical Device (GDPMD) is preferred.
• 10 years’ experience working with regulators and local distributors on local product testing issues resolution and management. Good knowledge of local regulatory requirement on local product secondary packaging and local product testing.
• Working knowledge and experience on managing/performing quality operation activities and the regulatory requirements for the importation, repackaging, release, storage and distribution of pharmaceutical and medical devices products (including sterile, liquid/solid products and cold chain) is preferred.
• Good knowledge and experience in working with cGMP and quality management system elements and guidelines (e.g. PIC/s, ICH, ISO9001 or ISO 13485) and cold chain product repackaging.
• Experience in managing supplier audits, internal audits, regulatory authority inspections.
• Experience in supplier/service provider oversight, audits, quality agreements, deviation/CAPA follow-up and change management is preferred.
• Ability to work independently and identify compliance risks and escalate when necessary
• Good sense of urgency and strong follow up
• Ability to manage complex projects and timelines in a matrix team environment
• Demonstrated interpersonal skills including strong negotiation skills
• Excellent teamwork and coordination skills

 

Key Skills, Abilities, and Competencies

• Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team
• Able to deliver results through influence, coordination and follow-up with stakeholders in a matrix environment, without relying on direct reporting authority
• Organization agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence of stakeholders
• Able to work cross-functionally and cross-culturally, in a global business environment
• Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed
• Able to adapt to changes and positively respond to changes
• Enthusiastic, resilient, dynamic, versatile. Display 'Can do' attitude
• Good interpersonal and communication skills
• Excellent verbal and writing skills and fluent in English and local language is desired

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)