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.
Qualifications
What you will bring to the role
- Must hold a certified pharmacist license in Korea.
- Excellent verbal and writing skills and fluent in both Korean and English is a must.
- Successful completion of relevant tertiary qualification
- 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.
Please use the attached Resume Format template when you submit the resume.
Submit in 2 languages please. (Korean & English)
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