QA Manager – Pharmaceutical Quality Operations

About the role

Santen Korea, part of the Santen Group, a specialist life sciences company focused on ophthalmology, is looking for a QA Manager to join its team in Korea. The role manages day-to-day quality operations so that importation, local testing, repackaging, storage, shipment/release and distribution comply with Korean regulations and Santen's global requirements. It also acts as local quality operations manager and deputy Quality Management Representative.

Key responsibilities

• Manage daily quality operations and act as deputy Quality Management Representative, supporting the QMS implementation, maintenance and continuous improvement.
• Coordinate with supply chain, regulatory affairs, safety vigilance, commercial stakeholders, warehouses, distributors, transporters and testing laboratories.
• Oversee QA/QC activities such as product receipt, warehousing checks, local testing coordination, batch/shipment release, repackaging controls, temperature excursion assessment, deviations and quality issue resolution.
• Act as responsible Pharmacist / Import Manager where required, ensuring quality checks, records and follow-up on import and wholesale activities.
• Maintain the local product quality compliance program, including local testing, secondary packaging, storage, distribution and post-market quality.
• Manage supplier and service provider quality oversight, including qualification, quality agreements, performance follow-up, change management, deviation/CAPA tracking and periodic reviews.

Required profile

• Certified pharmacist license in Korea.
• Fluent Korean and English, with excellent verbal and writing skills.
• Minimum 10-12 years in pharmaceutical and/or medical device quality, including commercial quality operations, GDP/GDPMD, local testing, importation, storage, release and distribution.
• Experience managing quality operations, audits, inspections and external service provider oversight in a matrix environment.
• Preferred: 10 years resolving local product testing issues with regulators and distributors, and experience with importation, repackaging, release, storage and distribution of pharmaceutical and medical devices (including sterile, liquid/solid and cold chain).

Required skills

• Knowledge of Good Distribution Practice (GDP) or Good Distribution Practice for Medical Devices (GDPMD) and local regulatory requirements on secondary packaging and local product testing.
• Strong interpersonal skills, leadership and ability to influence stakeholders without direct reporting authority.
• Able to work cross-functionally and cross-culturally in a global business.