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Manager, Quality Assurance, GQP Quality / 信頼性保証統括部 品質保証部 製品保証グループ 課長代理

Multiple Locations
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0125567 Date posted 07/02/2024 Location Multiple Locations

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Job Description

Please note this job requiresbusiness level Japanese in speaking, writing, and reading.









  • 国内外の製造所で発生した逸脱等、品質問題の市場流通品への影響評価、調査支援及び当局コミュニケーション
  • 国内外の製造所における日本の薬事コンプライアンス遵守の向上活動
  • 国内外の製造所との品質契約の締結及び維持管理
  • 新製品、製品移管及び継続的改善等のプロジェクト業務
  • 品質マネジメントシステムの運営とその継続的改善
  • 医薬品等製造販売業者の法令遵守にかかわる事項等



  • 医薬品等製造販売業(GQP)又は製造業(GMP)に係る業務の経験(3年以上が望ましい)
  • 部門間のクロスファンクショナルな業務の経験


    • コミュニケーション能力及び問題解決力の高い方


    • ビジネスレベルの英語力TOEIC700点以上が目安ですが、実務上のコミュニケーション能力を重視します)


    • 不問


    • 研究開発・製造技術・試験技術に係る業務経験
    • 海外ステークホルダー等との英語での業務経験
    • 少人数のメンバーの業務マネジメント経験(ユニット・チーム等)
    • 規制当局との業務経験
    • 医療機器QMS、再生医療等製品GCTP又はGDPにおける品質管理・品質保証の業務経験
    • 薬機法・GQP省令・GMP省令等の日本の規制要件に係る知識
    • プロジェクトマネジメントに係るスキル・経験
    • DD&Tに係るスキル・経験(Power Platformの作成・活用経験等)


    • 広い視野で幅広く社会に貢献したいという強い意志があり、いかなる困難な状況でも粘り強くやり遂げることができる方
    • 人財育成への意欲を持ち、組織の能力向上に貢献する意欲のある方


    • 医薬品等の品質保証、製造所管理に係る日本の法令、通知等の規制知識や規制当局とのコミュニケーション業務経験
    • プロジェクトマネジメント経験(新製品上市、プロセス改善等)
    • 海外製造所とのコミュニケーション経験
    • 多様なステークホルダーとの交渉・コンフリクトマネジメント経験







    • 大阪十三又は東京グローバル本社又は光工場(希望により相談可)
    • フレックスタイム制、テレワーク可(出社率60%程度)
    • 出張有り、1/月程度(製造所訪問、研修など

    Takeda Compensation and Benefits Summary:

    • Allowances: Commutation, Housing, Overtime Work etc.

    • Salary Increase: Annually, Bonus Payment: Twice a year

    • Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

    • Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

    • Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

    • Flexible Work Styles: Flextime, Telework

    • Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

    Important Notice concerning working conditions:

    • It is possible the job scope may change at the company’s discretion.

    • It is possible the department and workplace may change at the company’s discretion.


    Osaka (Juso), Japan

    Hikari, Japan, Tokyo, Japan

    Worker Type


    Worker Sub-Type


    Time Type

    Full time
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