외국계 제약 Medical Device 바이오 제약사 QA Sr.manager

▣ 담당업무
- 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
- 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"
*학력 : Over bachelor degree in relevant major (Knowledge on diagnosis mechanism (Biological, Immunization)

* 우대사항
ㆍPreferred employment in global, international IVD, pharmaceutical firms(>5 years)