담당업무

ㆍEnsure a Quality system is in place in compliance with Regulatory and ISO standards

ㆍLead QA organization (HC 20~30) to implement compliance, supplier quality, design quality, change control and internal audit, Post market surveillance

ㆍExpertise in ISO, GMP international standards

ㆍMake release decisions of finished products

자격요건

ㆍCareer : >15 years 

ㆍOver bachelor degree in relevant major (Knowledge on diagnosis mechanism (Biological, Immunization))

ㆍEnglish proficiency and pharmaceutical company experience required 

ㆍ Leadership experience in quality systems (> 10 years) in Pharmaceutical , medical device or IVD

ㆍExperience in leadership role in organization more than 10 HC

ㆍExperience in IVD with understaing of ISO 13485-2016, EU 2017/746(IVDR) and other rapid diagnostic device related international requirement

ㆍExcellent communication skill in English (in technical writing and conversation)

ㆍExceptional communication skills and ability to facilitate cross-functional cooperation

우대사항

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