Senior Manager,Quality Assurance, South Korea
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Job Location:
Seoul - South Korea
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
Responsibilities:
The Senior Manager QA (Korea) is responsible for leading and maintaining Medison Koreas 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 handson QA support to internal teams and external partners.
B. Quality Operations
- Lead Korea selfinspections 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 qualityrelated product release requirements.
C. Partner & Vendor Management
- Assess Koreabased distributors warehouses and logistics partners for GDP compliance.
- Ensure thirdparty facilities and quality systems meet Medison standards.
- Maintain Quality Technical Agreements with Korean partners.
D. CrossFunctional Collaboration
- Collaborate with RA Finance Commercial and Supply Chain teams.
- Support quality needs for launches regulatory submissions and local operations.
City:
Seoul
Requirements:
Required Education & Experience
- Bachelors degree in Pharmacy.
- Registered Pharmacist in South Korea.
- 58 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 decisionmaking skills.
Required Competencies
- Strong business acumen and crossfunctional leadership.
- Excellent written and verbal communication skills.
- High integrity and patientfirst mindset.
- Ability to manage multiple priorities independently.
- Effective collaboration with internal and external partners.
Key Skills
- Continuous Integration
- Quality Assurance
- FDA Regulations
- Root cause Analysis
- TFS
- Food Processing
- ICH Q10
- Jira
- Software Testing
- Quality Management
- Selenium
- Github
