Manager, Shonan Research Quality
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Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
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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. Were 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 companys 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:
Bachelors 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 PMDAs GLP inspection or Paper-Based Conformity inspection
タケダのDEI
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 companys discretion.
It is possible the department and workplace may change at the companys discretion.
Locations
Fujisawa JapanWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeRequired Experience:
Manager
Key Skills
- Quantitative Research
- Spss
- Clinical Research
- Data Collection
- Clinical Trials
- Research Experience
- Statistical Software
- Survey Design
- Qualitative Research
- Market Research
- Research & Development
- Project Coordination
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
