Senior Manager,Quality Assurance, South Korea

Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases.

Medison has a deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored-solutions for country-specific and regional commercialization, enabling emerging biotech companies to navigate local complexities and to expand their reach to patients in international markets.

Medison is rapidly growing in the international markets backed to 1996 of established operations in Israel, global infrastructure, and partnership network. Medison is headquartered in Israel, with its international markets HQ in Switzerland and commercial hubs across European Partner Markets, Americas.

The Senior Manager, QA (Korea) is responsible for leading and maintaining Medison Korea’s Quality Management System (QMS), ensuring compliance with MFDS, GDP, GMP, and global Medison quality standards. This role acts as the Responsible Import Pharmacist for Medison Korea and ensures that all importation, storage, handling, and distribution activities meet Korean regulatory and corporate quality requirements.

A. Quality Management & Compliance

• Serve as the Responsible Import Pharmacist for Medison Korea and fulfill all legal obligations.
• Ensure compliance with Korean MFDS regulations and global Medison QA requirements.
• Implement, maintain, and continuously improve the Korean QMS.
• Review and approve SOPs; ensure lifecycle management of controlled documents.
• Provide hands‑on QA support to internal teams and external partners.

B. Quality Operations

• Lead Korea self‑inspections for GMP/GDP operations.
• Lead Korea Management Review meetings and ensure continuous improvement.
• Manage deviations, CAPAs, change controls, and product complaints.
• Participate in regulatory inspections, partner audits, recalls, and mock recalls.
• Conduct vendor qualification, QTA creation, and vendor audits.
• Oversee quality‑related product release requirements.

C. Partner & Vendor Management

• Assess Korea‑based distributors, warehouses, and logistics partners for GDP compliance.
• Ensure third‑party facilities and quality systems meet Medison standards.
• Maintain Quality Technical Agreements with Korean partners.

D. Cross‑Functional Collaboration

• Collaborate with RA, Finance, Commercial, and Supply Chain teams.
• Support quality needs for launches, regulatory submissions, and local operations.

Required Education & Experience

• Bachelor’s degree in Pharmacy.
• Registered Pharmacist in South Korea.
• 5–8+ years of QA experience in pharmaceutical/biotech industry.
• Strong understanding of GMP, GDP, QMS, and regulatory compliance.
• Experience in audits, inspections, CAPA, and documentation.
• Strong analytical, communication, and decision‑making skills.

Required Competencies

• Strong business acumen and cross‑functional leadership.
• Excellent written and verbal communication skills.
• High integrity and patient‑first mindset.
• Ability to manage multiple priorities independently.
• Effective collaboration with internal and external partners.