This is what you will do:
【Manager, Japan Country Quality】
製造販売業者の信頼性保証部員として、当該役職者はGlobalAlxionのポリシーおよびSOPに従い、GQP QAグループを管理する。また、QMS管理業務、APJ手順書作成/制定、各品質協定規格締結/遵守、GMPコンプライアンス調査、製造所認定業務などの主要な活動を通じて、適正品質管理（GQP）およびGMDPの準拠を確保することを主たる責務とする。さらにAPJが製造販売業者として顧客クレーム対応も管理する。そのために社内外顧客、即ち、安全性管理部門、サプライチェーン、メディカル、薬事、CMC、営業・マーケティングなどと部門横断的に協働し、所轄当局や共同販売会社と連携・調整を行う。
You willbe responsible for
・開発品から市販後製品としてのGMDP/GQPプロセスのコンプライアンス管理
市販後製品の品質管理システム管理
製造販売業体制管理/主に品責・総責のサポート業務
市販後製品の品質関連業務
You will need to have:
・ 各種プロジェクト会議を主宰しリードする
QA週例会議において、担当業務におけるトピックを速やかに報告する。
QA月例会議において、品質関連情報のトレンド分析を行い、必要な場合と是正を推進する。
QMS会議主に変更・逸脱会議事案に対する対応方針などの検討する
Global組織とのコミュニケーション多数に参加し、APJの情報を報告・協議する。
We wouldpreferfor you to have:
Bachelor’s degree plus more than 5 years-experience in pharma or bio industry
CMC and QA/QC related technical experiences (manufacturing, analytical)
Knowledge of JPAL/ GQP/ GMP requirements
Expert of Quality Management System
Project Management skill (planning, problem solving)
Communication skill
Negotiation skill
Facilitation skill
Problem solving skill
Leadership Capabilities
Date Posted
11-6月-2026
Closing Date
09-6月-2027
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com Alexion participates in E-Verify.
Alexion, AstraZeneca Rare Disease is focused on pioneering new possibilities for the rare disease community. We are driven by a mission to change what it means to live with a rare disease.
A leader in rare disease for more than three decades and today continues to build a diversified pipeline across disease areas with significant unmet need, using an array of innovative modalities.
As part of AstraZeneca, Alexion is continually expanding its global geographic footprint to serve more rare disease patients around the world. It is headquartered in Boston, US.
Alexion’s pioneering legacy in rare disease is rooted in being the first to translate the complex biology of the complement system into novel medicines. Alexion pushes boundaries to accelerate discovery of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the world and continues to expand its reach to benefit more people globally.
GL/NP/0116
GL/NP/0095
Community Guidelines: https://bit.ly/39x9gqy
