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Specialist, Quality Project Management, Hikari Site

Hikari, Yamaguchi
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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 R0120310 Date posted 04/18/2024 Location Hikari, Yamaguchi

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Job Description

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

About Takeda

”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us. 

Takeda isa global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, whichhas been passed down since the company’s founding. Takeda-ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.



  • A member of Hikari Quality, become a Quality Transformation expert.
  • Responsible for research and analysis on digital market trends to identify technological advancements opportunities, and provide recommendations based on the market analysis.
  • Develop the novel technology introduction plan aligned with Hikari Quality roadmap utilizing system engineering skillset, manage or execute those transformation projects collaborating with cross-functional stakeholders.
  • Propose and/or execute Hikari Quality DD&T initiatives.
  • Collaborate and communicate across the Quality organization to promote Quality transformation including Hikari Quality Leadership Team (HQLT) as well as cross-functional stakeholders.
  • Implement various change/transformation and continuous improvement initiatives to successfully transform Hikari Site Quality organization and mind-set.
  • Lead or manage a Quality Culture initiative through partnerships with stakeholders.
  • Responsible for a timely and effective communication and escalation process to Head of Quality Transformation and Hikari Quality Leadership Team (HQLT).
  • 光品質部門のメンバーは、品質変革の専門家となる。
  • デジタル市場動向の調査・分析を行い、技術進化の機会を特定し、市場分析に基づいて提言を行う責任を負う。
  • システムエンジニアリングスキルを活用して、光品質ロードマップに沿った新規技術導入計画を策定し、部門横断的なステークホルダーと協力して、これらの変革プロジェクトを管理又は実行する。
  • 光クオリティDD&Tイニシアチブを提案及び/又は実行する。
  • 光クオリティリーダーシップチーム(HQLT)だけでなく、部門横断的な利害関係者を含め、品質組織全体で協力し、コミュニケーションを行い、品質の変革を促進する。
  • 光工場品質部門の組織及びマインドセットの変革を成功させるために、さまざまな変更/変革及び継続的改善イニシアチブを実施する。
  • ステークホルダーとのパートナーシップを通じて、品質文化イニシアチブを主導又は管理する。
  • Quality Transformation Head及び光クオリティリーダーシップチーム(HQLT)への適時かつ有効な情報伝達及び上申プロセスに責任を負う。


  • Manage or execute defined strategic Quality transformation project.
  • Research and analyses on digital market trends to identify technological advancements opportunities.
  • Develop the novel technology introduction plan including system engineering perspective.
  • Manage or facilitate Hikari Quality specified project and Quality culture initiatives in the organization.
  • Coordinate or execute Quality projects, initiatives, process improvements and best practice sharing across the Site quality organization, including appropriate tools, and training.
  • Promote the collaboration with the other function in Quality and GMSGQ organization.
  • Stay up-to-date with the latest industry developments and emerging technologies.
  • Execute adherence to EHS program.
  • 定義された戦略的品質変革プロジェクトを管理又は実行する。
  • デジタル市場動向を調査・分析し、技術進化の機会を特定する。
  • システム工学的観点を含めた新規技術導入計画を策定する。
  • 組織における光品質指定プロジェクト及び品質文化イニシアチブを管理又は促進する。
  • 適切なツール及びトレーニングを含め、サイトの品質組織全体で品質プロジェクト、イニシアチブ、プロセス改善及びベストプラクティスの共有を調整又は実行する。
  • 品質及びGMSGQ組織内の他部門との連携を推進する。
  • 業界の最新の発展や新たなテクノロジーについて常に最新情報を入手する。
  • EHSプログラムの遵守を実行する。


Technical/Functional (Line) Expertise

  • Knowledge in Digital, automation, MES, LIMS, AGILE or labo excellence are preferable.
  • Proven experience in planning and implementing new technology adoption and digital strategies.
  • Strong background in system engineering or data science.
  • Excellent analytical and problem-solving skills.
  • Knowledge of digital marketing and e-commerce trends is a plus.
  • Analytical and problem-solving skills to initiate quality transformation project and continuous improvement opportunities.
  • Adaptive communication and presentation skills to effectively reach various levels in Japanese.
  • Knowledge of the local and international regulatory regulations including GxP, ICH, other related guidelines.
  • Knowledge or Skilled in Microsoft Office applications (Excel, Powerpoint, Word, Power BI), AI/RPA, TrackWise Deviation/CAPA, Change Control Management (CCM), SAP and Electronic Batch Management (EBM) systems preferred.
  • デジタル、オートメーション、MES、LIMS、AGILE、ラボエクセレンスの知識(あると望ましい)
  • 新規技術の採用及びデジタル戦略の計画及び実施における実績
  • システムエンジニア又はデータサイエンスに強いバックグラウンド
  • 優れた分析スキルと問題解決スキル
  • デジタルマーケティングや電子商取引の動向に関する知識(あると望ましい)
  • 品質変革プロジェクトと継続的な改善機会を開始するための分析スキルと問題解決スキル
  • 日本人の様々なレベルに効果的に到達するための適応的コミュニケーションとプレゼンテーションスキル
  • GxP、ICH、その他の関連ガイドラインを含む現地及び国際的な規制に関する知識
  • Microsoft Officeアプリケーション(Excel、PowerPoint、Word、Power BI)、AI/RPA、TrackWise逸脱/CAPA、変更管理管理(CCM)、SAP及び電子バッチ管理(EBM)システムに関する知識又はスキル


  • Good interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team.
  • Adopt and exemplify the Takeda leadership behaviors throughout the GQ organization and Hikari Site.
  • Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals.
  • 信頼できる関係を構築し、従来の考え方に建設的に挑戦し、男女の信頼を得て、主要なステークホルダーに影響を与え、チームリーダーやチームメンバーとして協力し、情報を共有し、チームで結果を出す能力などの優れた対人スキル
  • GQ組織及び光工場全体でタケダのリーダーシップ行動を採用し例示する。
  • 変革エージェントとして行動するだけでなく、チーム目標の達成に向けてチームメンバーを効果的に主導し、動機付けする能力がなければならない。


  • Interacts with the HQLT and Quality leaders.
  • Interacts frequently with subordinates, functional peers, and GMS counter partners.
  • HQLT及び品質部門のリーダーと連携する。
  • 部下、部門の同僚、GMSカウンターパートナーと頻繁に交流する。


  • Should be current in knowledge of state-of-the art processes and systems related to quality as well as control of the products.
  • Identify and implement strategic opportunities to drive cost reductions/quality & process improvements in site-business.
  • Lead and engage employees by initiatives of “Qualtiy Culture”, "eAGILE" "Digital" to drive continuous improvements.
  • 製品の管理だけでなく、品質に関連する最新のプロセスやシステムについても最新の知識を有していなければならない。
  • サイトの事業におけるコスト削減/品質及びプロセス改善を推進するための戦略的機会を特定し、実施する。
  • 「Quality Culture」 、 「eAGILE」 、 「Digital」 の取り組みにより、従業員をリードし、エンゲージメントを図り、継続的な改善を推進します。


  • Key stakeholders include but not limited to: Quality Control, Quality Assurance, Manufacturing, Supply Chain, Distribution, DD&T, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.
  • 主要な利害関係者には、品質管理、品質保証、製造、サプライチェーン、流通、DD&T、製造科学、ファーマコビジランス、薬事及び保健当局が含まれるがこれらに限定されない。


  • Bachelor’s degree in IT and digital, system engineering, data analysis, chemistry, Pharmacy, Engineering, Biology or related discipline is preferable.
  • An experience in the following areas in the pharmaceutical industry: Quality assurance, Quality Control, Quality system, Manufacturing, Excellence; understanding of the requirements for manufacturing, computer systems and project management.
  • Basic knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
  • Good leadership skills (i.e. Communication, Project Management, Decision Making, Problem Solving, Team building and etc.)
  • A certain level of English skill is preferable (both verbal and written)
  • IT及びデジタル、システム工学、データ解析、化学、薬学、工学、生物学又は関連分野における学士号が望ましい。
  • 製薬業界における以下の領域での経験:品質保証、品質管理、品質システム、製造、卓越性;製造、コンピュータシステム及びプロジェクト管理の要求事項の理解
  • FDA CFR、ICH、GMP、guなど、医薬品に適用される規制及び法律に関する基礎知識
  • 優れたリーダーシップスキル(コミュニケーション、プロジェクト管理、意思決定、問題解決、チームビルディングなど)
  • 読み書き・会話において一定の英語力があることが望ましい。


  • Some travels will be required.
  • This job description is not designed to be a complete list of all duties and responsibilities required of the position.

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.


Hikari, Japan

Worker Type


Worker Sub-Type


Time Type

Full time
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Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

We're Steadfast In Our Commitment to Four Key Imperatives


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.


Create an exceptional people experience.


Protect our planet.

Data & Digital

Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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About our location

Hikari, Yamaguchi

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