RECRUIT DIRECT SCOUT リクルートダイレクトスカウト PRODUCED BY RECRUIT
RECRUIT DIRECT SCOUT リクルートダイレクトスカウト PRODUCED BY RECRUIT
    エージェント求人

QA/CMC Director

年収非公開

企業名企業名非公開

所在地東京都世田谷区

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

  • GQP
  • CMC
  • QMS
  • GMP

- 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).

語学

英語で日常会話が可能

勤務条件

雇用形態

正社員

給与

年収非公開

勤務時間

休憩60分

09:00〜18:00 Work from home 2-3 days per week

休日・休暇

内訳:完全週休2日制、土曜 日曜 祝日

社会保険

健康保険 厚生年金 雇用保険 労災保険

備考

勤務地

配属先

転勤

Setagaya

住所

東京都世田谷区

制度・福利厚生

制度

リモートワーク可

その他

制度備考

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