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Lead, Quality System

Req # JR - 180086 Location Minato, Tokyo, Japan Job Category Quality Date posted 07/24/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Lead, Quality System

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This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

【概要】
・　医薬品の品質管理業務及び医療機器の品質管理監督システムの構築及び運用管理、医薬品品質システムのサポート
・　医薬品及び医療機器の適合性調査、自己点検、内部監査、外部監査に係る業務
・　医薬品及び医療機器の製造販売業の運営と維持に係る業務
・　品質保証に係る業務

【職務内容】
１．品質システムに係る業務
- 医薬品の品質管理業務及び医療機器の品質管理監督システムの構築及び維持管理（GQP/QMS）
‐　医薬品品質システムのサポート（GMP）
‐　管理監督者照査（マネジメントレビュー）の管理・実施・記録
‐　文書管理システム、グローバル及び国内の文書及び記録の維持管理業務
‐　教育訓練計画の立案、実施、維持
‐　教育訓練システムの維持と管理

２．監査・調査に係る業務
‐　医薬品及び医療機器の定期適合性調査の申請書作成及び行政窓口、実施対応
‐　自己点検（GVP含む）、内部監査の計画、実施、管理
‐　行政及びコーポレート監査（調査）の管理、窓口、調査者対応
‐　内部監査員の育成

３．品質保証に係る業務
- 担当製品の品質保証業務
　　担当製品の品質保証業務
　　変更管理の対応
　　不適合製品の措置管理
　　製造所とのコミュニケーション
　　品質標準書及び製品標準書の維持及び管理
　　回収、出荷停止に係る対応及び記録の管理
　　新製品導入対応

【求められるスキル・経験】

医薬品を優先的に希望するが、医療機器も含め品質業務に5年以上の経験を有し、品質システムに関する業務に3年以上の経験を有する。

【品質システムに係る業務】
‐　薬機法、QMS省令、GQP省令、GMP省令、その他関連法規に関する知識及び経験

【監査・調査に係る業務】
‐　薬機法、QMS省令、GQP省令、GMP省令、その他関連法規に関する知識及び経験
‐　承認書が読めること
‐　定期適合性調査対応経験
‐　内部監査員資格（社内あるいは社外）を有すること
‐　行政監査（調査）対応の経験

【品質保証に係る業務】
‐　薬機法、QMS省令、GQP省令、GMP省令、その他関連法規に関する知識及び経験
‐　医薬品及び医療機器製品を理解できる知識
‐　協調性、分析力、交渉力、英語力、未経験の分野への挑戦力
‐　承認書が読めること

【英語力】読み書きできるレベル

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Address

Explore this location 30F Granpark Tower, 3-4-1 Shibaura
Minato-ku, Tokyo
108-0023
Japan Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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