募集要項
- 仕事内容
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Leads the organization to identify and mitigate risks throughout the drug/device lifecycle to ensure patient safety and data integrity.
Initiates and manages any quality and compliance topics to continuously improve our Quality Management System.
Provides quality and compliance consultancy to enable fast and efficient research and development, market authorizations and maintain licenses for our portfolio of products within a specific (R)OPU.
Contributes R/OPU insights into the Global Quality Medicine Strategy and execute the strategy at R/OPU level.
Quality strategy and governance:
Culture and organization:
Processes and Procedures:
Regulatory Inspections:
Audits:
Supplier Management:
Risk and issue management:
Management of Non Compliances:
- 応募資格
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- 必須
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•Expert in ICH GcP and applicable regulations (several years experience in clinical trial management and/or in depth knowledge of clinical development process) or
•Expert in ICH GvP and applicable regulations (several years experience in pharmacovigilance and/or in depth knowledge of pharmacovigilance processes)
•Direct experience with / participation in regulatory authority inspections
•5+years experience in Quality and Compliance related job
•Bachelors in a life science or other scientific discipline with several years of work experience
•New technologies: knowledge of specific technologies e.g. data collection technologies and the associated (potential) regulations, such that role can provide advice in their use within the (R)OPU
•Required English speaking CEFR level: B2
- 歓迎
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•External regulations: knowledge of the relevant regulatory requirements for QM and functional processes to be able to assess the risks for non-adherence to external regulations and provide mitigation strategies or how to address issues
•Master's degree preferred
•Ability to travel regionally and internationally as needed
- 雇用形態
- 正社員
- 勤務地
- 東京都
- 年収・給与
- 600万円 ～ 1199万円
- 待遇・福利厚生
- Social insurance
- 休日休暇
- Full 2 holiday week system (Sat/Sun) national holidays, New year’s holiday, Annual Leave
