▷ 회사: 외국계 제약, 바이오 기업

▷ 회사위치: 경기도

▷ Responsibilities

- 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 quality standards

▷ Requirements

- 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 understating 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

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

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

▷ 상기 job opening에 관심 있으신 분께서는 아래 담당자에게 연락바랍니다.

   담당: 김종민 이사 (jmkim@hijob.co.kr / 070-7126-1950)