Manager, Shonan Research Quality

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Job 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。

タケダはグローバルな研究開発型のバイオ医薬品のリーディングカンパニーです。従業員は創業時から受け継いできたタケダの価値観であるタケダイズム（誠実＝公正・正直・不屈）を道しるべとしながら、患者さんに寄り添い（Patient）人々と信頼関係を築き（Trust）社会的評価を向上させ（Reputation）持続可能な事業を発展させる（Business）を日々の行動指針としています。

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

Takeda is a global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, which has been passed down since the company’s founding. Takeda-ism incorporates Integrity, 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.

OBJECTIVES/PURPOSE

• Independently carries out activities to ensure that non-clinical Research study activities (e.g., GLP, non-GxP submission relevant) conducted in-house or outsourced are in compliance with applicable regulations and Takeda requirements.
• Leads supplier quality oversight/qualification activities for externalized non-clinical studies.
• Partners with stakeholders and team members to advance quality, compliance, and data integrity principles across Research processes, activities, and programs.
  

ACCOUNTABILITIES

• Lead qualification and compliance assessments (either by direct audit participation or via management of contract auditors) of external service providers conducting non-clinical studies and other related Research activities.
• Manage quality initiatives across various internal and external groups (stakeholders and third parties) to maintain quality, compliance and consistency across programs and projects in Research.
• Conduct audits of internal non-clinical studies to assure data integrity and suitability of reports and associated raw data to support regulatory submissions. Collaborate with stakeholders to resolve findings in a compliant and timely manner.
• Provide leadership and subject matter expertise to ensure timely, well-documented, and compliant 
• Effectively interact with quality team members and internal stakeholders to support projects and goals.
• Support regulatory submission and inspection pertaining to stakeholders and suppliers.
• Independently and proactively identify quality and compliance gaps, communicate to management, and propose solutions.  Lead implementation of endorsed solutions.
• Read and interpret various regulations and guidance documents and assess compliance.
• Additional duties as assigned.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Minimum requirements:

Bachelor’s degree in Chemistry, Biology, Engineering or related field.

Minimum of 5 years of experience in the pharmaceutical industry in any of following roles;

• GLP personnel
• QA in a GxP environment
• Researcher conducting regulatory submission relevant DMPK, Pharmacology, or Toxicology studies

Demonstrated ability to collaborate with and achieve results through others, the ability to build strong and sustainable relationships and the capability to interact within all levels of the organization.
Clear, concise and consistent in written and verbal communications.

Preferred requirements:
GLP QAU experience
Experience in receiving PMDA’s GLP inspection or Paper-Based Conformity inspection

タケダのDE＆I

Better Health, Brighter Future

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.

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