QA Manager (1 Year Contract)

About the role

Santen Korea, a specialist life sciences company focused on ophthalmology, is looking for a QA Manager on a 1-year contract, based in Seoul. The role leads and oversees quality operations so that importation, testing, repackaging, storage, release, shipment and distribution run compliantly, efficiently and without interruption under Korean regulations and Santen's global quality standards. It is the local quality operations lead and deputy Quality Management Representative, and also acts as Responsible Pharmacist/Import Manager where required.

Key responsibilities

• Manage day-to-day quality operations and ensure compliant execution of importation, local testing, repackaging, storage, shipment/release and distribution.
• Support the implementation, maintenance and continuous improvement of the local Quality Management System (QMS).
• Coordinate with Supply Chain, Regulatory Affairs, Safety Vigilance, commercial stakeholders, warehouses, distributors, transporters, testing laboratories and other service providers.
• Oversee QA/QC activities such as product receipt, warehousing checks, local testing coordination, batch/shipment release, repackaging controls, temperature excursion assessment, deviation handling and quality issue resolution.
• Maintain the local product quality compliance program, including product testing, secondary packaging, storage, distribution and post-market quality activities.
• Manage supplier and service provider oversight, including qualification, quality agreements, performance follow-up, change management, deviation/CAPA tracking and periodic reviews.
• Provide quality leadership for post-market surveillance, product launches, variations and business projects, and resolve quality issues promptly.

Required profile

• Bachelor's degree in Science or a related field.
• Certified pharmacist license in Korea.
• 8+ years of experience in pharmaceutical and/or medical device quality, with expertise in quality operations, GDP/GDPMD, importation, testing, storage, release and distribution.
• Proven experience developing, implementing and maintaining QMS compliant with Korean regulations and global standards.
• Experience resolving product quality and compliance issues with regulators, distributors, testing laboratories and service providers.
• Fluency in both Korean and English is a must.

Required skills

• Strong knowledge of cGMP, GDP, PIC/S, ICH, ISO standards, cold chain operations and product repackaging.
• Managing supplier oversight, quality agreements, audits, inspections, deviations, CAPAs, change controls and compliance programs.