グローバル品質保証マネージャー

---

Job details

Company overview

We are a leading biotechnology company focusing on cutting-edge technologies. Our key areas of focus include cancer, kidney disease, and immune disorders. In the field of antibody medicine, we are committed to developing innovative new drugs by combining technologies such as the "Potelligent technology" (which enhances antibody activity by 100 times) and "Human Antibody-Producing Mouse." We are dedicated to establishing a global research and development framework to provide medicines to a large number of patients.

Responsibilities

• QA業務に対する助言と支援
• 保健当局とのコミュニケーションと対応
• ディストリビューターの管理と監視
• GMP/GDPコンプライアンス活動
• 内部監査と品質協定管理

Requirements

必須条件：

• ポスト承認品質保証の基本的な専門知識
• GMP経験（最低3年）
• 製薬申請に関する知識と実務経験
• GMP/GDP/GQPに関する最新動向の理解

Salary

6.36 - 12.6 million yen

Location

Tokyo