エージェント求人

QA/CMC Director

年収非公開

企業名非公開

東京都世田谷区

募集要項選考・企業概要

職務内容

職種

医薬品CMC薬事
医薬品品質保証
医療機器CMC薬事

仕事内容

GQP
QA/Quality Assurance
CMC

-Establish quality agreements with manufacturers, conduct audits, and ensure proper manufacturing and quality controls. -Participate in global quality meetings and make GQP judgments. -Evaluate final product quality and decide on market release. -Analyze product quality issues and implement improvement and prevention measures. -Manage manufacturing changes, deviations, and regulatory responses. -Ensure compliance with document preparation, storage, and regulatory requirements. -Oversee manufacturing site information to avoid discrepancies. -Prepare application forms (CTD M1.2, CTD 3) and documents for medical devices.

求める能力・経験

- B.S. in life sciences; advanced degree preferred. - 10+ years in Pharmaceutical Quality leadership. - 5+ years in pharmaceutical Regulatory CMC, including RA CMC experience. - Experience with regulatory bodies (PMDA, MHLW). - Strong understanding of GQP/GMP/QMS regulations. - Practical experience in pharmaceutical quality, distribution, manufacturing, or QC roles. - Business-level English (writing, reading, speaking).