[ 담당업무 ] 
- Lead and manage the site's Quality Management System (QMS), ensuring strict compliance with global and local regulations (MFDS, FDA, etc.).
- Oversee and manage key quality processes including Change Control, Deviation, and CAPA management, driving effective Root Cause Analysis (RCA) and prevention.
- Execute the final Product Release/Disposition decisions, approving all critical documents such as Batch Records and validation protocols.
- Plan and lead internal audits, and serve as the main liaison for regulatory inspections and external customer/corporate quality audits.
- Provide strong leadership and technical coaching to the QA team, fostering a culture of quality and continuous improvement across the organization.

[ 자격조건 ]
- 5+ years of experience in the pharmaceutical or clinical CRO industry
- Proven experience in QA audit planning, execution, and regulatory inspection management
- Experience in PV or clinical operations
- Bachelor’s degree or higher in Biology, Chemistry, Pharmacy, or a related field.


[ 전형방법 ]
1차 서류전형
2차 면접전형

[ 제출서류 ]
국문.영문이력서.경력기술서포함(각종 증빙서류는 서류전형합격자에 한해 추후제출)
이메일: carly.lee@peoplework.co.kr******@*******.***
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