• Maintain and improve Quality Management Systems (QMS) across LSHC and non-LSHC operations in compliance with regulatory, customer and internal requirements.
• Manage quality processes, including Deviations, CAPAs, Change Controls, Risk Assessments and investigations, using electronic QMS platforms where applicable.
• Prepare, review and maintain SOPs, Work Instructions and other controlled quality documentation.
• Coordinate and support facility /equipment Qualification and Validation activities (IQ/OQ/PQ) for applicable GxP operations.
• Coordinate internal, customer and external audits, including findings and follow-up actions.
• Monitor Quality and Customer KPIs, including Service Quality, and support Operations in root cause analysis and corrective actions.
• Promote Quality culture through communication, training and collaboration with Operations across business sectors.
• Support cross-functional quality improvement initiatives and compliance projects.

Essential Requirements

• 5 ~ 10 years of relevant QA experience, preferably in GDP/ISO-regulated environments.
• Strong working knowledge of pharmaceutical distribution regulations (KGSP/GDP) and applicable medical device regulatory requirements in Korea.
• Hands-on experience in QMS operations, including Deviations, CAPAs, Change Controls, Risk Assessments and investigations.
• Experience in SOP/WI preparation, quality audits and Qualification/Validation documentation.
• Working knowledge of ISO 9001-based Quality Management Systems.
• Good written and verbal English communication skills.
• Willing to travel to local site area

Preferred Requirements

• Experience in pharmaceutical or medical device logistics, warehousing and distribution.
• Knowledge or practical experience with ISO 13485/GDP.
• Hands-on experience in facility/equipment Qualification and Validation (IQ/OQ/PQ).
• Project management experience in quality improvement or cross-functional compliance initiatives.