외국계헬스케어 기업 QA부서장

QA Senior Manager (부서장)

[주요업무]
• Ensure a Quality system is in place in compliance with Regulatory and ISO standards
• Lead QA organization (HC 20~30) to implement compliance, supplier quality, design quality, change control and internal audit, Post market surveillance
• Expertise in ISO, GMP international standards
• Make release decisions of finished products
• Lead Quality Management Remediation Project to meet Abbott quality standards

[자격요건]
•Over bachelor degree in relevant major (Knowledge on diagnosis mechanism (Biological, Immunization)
• Leadership experience in quality systems (> 10 years) in Pharmaceutical , medical device or IVD
• Experience in leadership role in organization more than 10 HC
• Experience in IVD with understaing of ISO 13485-2016, EU 2017/746(IVDR) and other rapid diagnostic device related international requirement
• Excellent communication skill in English (in technical writing and conversation)
• Exceptional communication skills and ability to facilitate cross-functional cooperation
• Preferred employment in global, international IVD, pharmaceutical firms(>5 years)