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)