Please note this job requiresbusiness level Japanese in speaking, writing, and reading.
"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-ismincorporates and 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.
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).
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.
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
Leadership
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.
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.
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)
This job description is not designed to be a complete list of all duties and responsibilities required of the position.
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
Click to find out Takeda's Diversity, Equity & Inclusion
Description · Please note this job requires business level Japanese in speaking, writing, and reading. · タケダの紹介 · タケダは「世界中の人々の健康と輝かしい未来に貢献する」ことを企業の存在意義(パーパス)としています。そして目指す未来を共有しながら、一人ひとりが自分の可能性を引き出し、お互いの個性を認め合う、多様性にあふれた先進的な組織作りに取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。 ...
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Description · Please note this job requires business level Japanese in speaking, writing, and reading. · タケダの紹介 · タケダは「世界中の人々の健康と輝かしい未来に貢献する」ことを企業の存在意義(パーパス)としています。そして目指す未来を共有しながら、一人ひとりが自分の可能性を引き出し、お互いの個性を認め合う、多様性にあふれた先進的な組織作りに取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。 ...
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Description · Please note this job requires business level Japanese in speaking, writing, and reading. · 240年の歴史の中でタケダでは常に患者さんを中心に考え、世の中(世界中)の人々により健やかで輝かしい未来をお届けすることを目指してきました。そして従業員一人ひとりにそれぞれの能力と熱意に応じた成長の機会を提供することにも組んで取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。 · 【募集部門の紹介 ...
Description · Please note this job requires business level Japanese in speaking, writing, and reading. · タケダの紹介 · タケダは「世界中の人々の健康と輝かしい未来に貢献する」ことを企業の存在意義(パーパス)としています。そして目指す未来を共有しながら、一人ひとりが自分の可能性を引き出し、お互いの個性を認め合う、多様性にあふれた先進的な組織作りに取り組んでいます。私たちと一緒に、世界中の人々のいのちに貢献し、さらなる成長と活躍を目指しませんか。 ...