[KOREA] Senior Quality Assurance Manager (People Manager role) at Santen

Seoul, , South Korea -

Full Time

Start Date

Immediate

Expiry Date

15 Feb, 26

Salary

0.0

Posted On

17 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Management System, Good Distribution Practice, Good Manufacturing Practice, Pharmacy, Regulatory Compliance, Vendor Management, Stakeholder Management, Leadership, Communication Skills, Continuous Improvement, Pharmaceutical Industry, Medical Devices, Change Management, CMO Management, Fluency in English, Fluency in Korean

Industry

Pharmaceutical Manufacturing

Description

Company Description Santen is a specialized company with a proud 130-year heritage focused exclusively on eye health. As a Japan-originated, global company with our footprint in over 60 countries and regions, our mission is to provide essential and significant value to patients and society through our products and services created from our expertise in ophthalmology and from the patient’s perspective. Job Description Management of overall quality operations for Santen in Korea to ensure its compliance with applicable local regulatory authority and Santen’s global requirements for importation, local testing, repackaging, storage and distribution of Santen products. Responsible as the Quality Management Representative Role for Santen in Korea and ensure the local QA operation/activities and the development, implementation and maintenance of a systematic, effective and efficient local Quality Management System (QMS) as per applicable local regulatory authority and Santen’s global requirements. Perform quality activities and resolve quality issues for Santen in Korea to support the continuous supply of Santen products in these countries in compliance to applicable local regulatory authority and Santen’s global/release requirements. Act as responsible pharmacist/importing manager if required. Responsible to ensure all vendors including suppliers/service providers used by Santen in Korea is compliant with all corporate/regional and regulatory cGMP/cGDP guidelines and SOPs. Maintain a quality compliance program for all vendors including an effective change management system. Management all relevant regulatory inspections or certification audits in Korea (GDP/GDPMD by regulators or certification body) to ensure successful maintenance / renewal of license and certification. Responsible to ensure Santen products produced by CMOs in Korea/Asia is compliant to applicable established and registered product specifications and requirements. Qualifications Bachelor’s degree in Pharmacy (Licensed Pharmacist in Korea) Minimum 15 years of experience in the pharmaceutical and/or medical device industry, focused on quality functions At least 5 years in a GMP manufacturing plant environment Around 10 years in a commercial quality environment Approximately 5 years in a quality supervisory or leadership role Minimum 5 years of people management experience (highly preferred) Strong knowledge and hands-on experience in developing, implementing, and maintaining Quality Management Systems (QMS) in compliance with Good Distribution Practice (GDP) or Good Distribution Practice for Medical Devices (GDPMD) — experience within the Korean market is essential Proven expertise in GDP, GMP, and GIP (must-have) Demonstrated experience in CMO management (highly preferred) Fluency in both English and Korean, with excellent stakeholder management and communication skills Additional Information Grow your career at Santen A career at Santen is an opportunity to make a difference. We aspire to contribute to the realization of “Happiness with Vision” by providing eye health products and services to patients, consumers, and medical professionals around the world. Guided by our CORE PRINCIPLE, “Tenki ni sanyo suru”, Santen is engaged in the global research & development, manufacturing, and sales and marketing of pharmaceutical products in ophthalmology. 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 note that team assignments may be subject to future changes

Responsibilities

Manage overall quality operations for Santen in Korea, ensuring compliance with local regulatory authority and global requirements. Oversee the development and maintenance of an effective Quality Management System and resolve quality issues to support continuous supply of products.