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Associate Director Regional Lead, Commissioning & Qualification

Jūsō-honmachi, Japan


Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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

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

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

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

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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

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Associate Director Regional Lead, Commissioning & Qualification

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Job ID R0010669 Date posted 09/05/2019 Location Jūsō-honmachi, Japan

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Job Description

Please note that this job requires native level English(definitely)/Japanese(hopefully) language command not only in speaking, but also in business writing and reading. (English language : TOEIC参考730点以上)



Department introduction

Global Engineering is maintaining Takeda long-range capital investment strategy and portfolio and leads as the center of expertise for engineering across the production network. We make sure the company introduces best practices and up-to date technologies and implements global strategies on engineering, maintenance, project management, automation and qualification. Reginal Engineering Japan has responsibility for Japan site. (Osaka, Hikari, Fukuchiyama, NIhon seiyaku Narita, Nihon seiyaku Osaka)


  • As member of the regional Engineering Team, the Regional Lead, Commissioning & Qualification provides guidance and support to all site Project Management and Engineering Services Teams on Commissioning, Qualification and Validation activities within the region. The Regional Lead reports to the Regional Head of engineering and will support both the site leadership teams as well as the Global Engineering Team to drive business performance consistent with the TAKEDA´s core values of Patient – Trust – Reputation – Business.
  • The Regional Lead is responsible for the implementation of good Commissioning and Qualification (C&Q) plans and practices and support the sites on subsequent planning and execution of validation activities.
  • The Regional Lead will work closely with the Site Engineering Services Lead and teams and will liaise with external qualification service providers to ensure proper C&Q staffing options for capital investment projects and routine operations.


  • Drive Best highest safely standards during commissioning and qualification at all sites within the region.
  • Develop and ensure the implementation of a Regional strategic Qualification Master Planning process in close cooperation with Regional Quality and the Sites.
  • Guide and support the Site Engineering Services and Project Management Teams in all aspects of C&Q planning and execution in Capital projects and operations.
  • Facilitate discussion with local and regional Engineering and Quality Teams to optimize resource utilization and timelines without compromising results in C&Q as well as validation activities.
  • Support a strong implementation of Good Engineering Practices, GMP standards and compliance to applicable regulations in C&Q activities in the region.
  • Provide guidance to site and regional project management teams in GxP compliance from project initiation till handover to facilitate positive C&Q and validation results.
  • Support the site teams in developing and optimizing the respective site qualification Master Plans.
  • Ensuring the sharing and application of best practices.
  • Review site adherence to C&Q Global Standards.
  • Facilitate the implementation and optimization of site re-qualification approaches and plans in close cooperation with local Quality, Engineering and operation teams.
  • In cooperation with procurement, develop optimized regional sourcing strategies for C&Q services.
  • Close collaboration with regional and global engineering and quality teams.
  • Foster a professional network (internal and external to Takeda) constantly assessing and seeking best practices for use at the site and for the broader Takeda network. Active participation at ISPE or similar networks is encouraged.



  • 高専・大学(工学系)卒業以上(専攻:機械系、電気・計装系、生産システム系等)
  • Degree in engineering  (mechanical / process / chemical) or pharmaceutical science (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent
  • Languages: Fluent business level English capability

    Fluent Japanese writing and verbal communication skills required

  • Experience: At least 10 years in Commissioning & Qualification or GMP regulated project management or operations, including 5+ years as C&Q lead of sizeable investment projects in the pharmaceutical industry.
  • High communication skills, analytical mind-set, ability to work under pressure
  • GxP/QA knowledge
  • Innovative thinking
  • Building relationships and teamwork
  • Strong know how in qualification and validation processes
  • Can establish and coordinate service contracts with C&Q providers

[Additional desired Skills]

  • Experience in Manufacturing or operations


  • 諸手当:通勤交通費、借家補助費、勤務時間外手当など
  • 昇給:原則年1回 
  • 賞与: 原則年2回
  • 勤務時間:本社(大阪市中央区・東京都中央区)9:00~17:30、工場(山口県光市・大阪市十三)8:00~16:45、研究所(神奈川県藤沢市)9:00~17:45
  • 休日:土曜、日曜、祝日、メーデー、年末年始など(年間123日程度)
  • 休暇:年次有給休暇、特別有給休暇、リフレッシュ休暇、産前産後休暇、育児休暇、



Empowering Our People to Shine


Osaka (Juso), Japan

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0010669

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