募集要項
- 仕事内容
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Summary
• Provide Quality guidance to Japan Clinical Development teams.
• Drive inspection readiness for PMDA GCP inspections in assigned portfolio to assure successful outcomes during submission-related inspections.
• Support Director of development quality and Identify, evaluate, and drive the remediation of fundamental risks and quality issues within Clinical Development program(s) to drive quality, in collaboration with Clinical Development, in the company’s portfolio.
Principal Responsibilities
• In alignment with Sr. Director of development operations and director of development quality, develops a scheme related to proactive and sustainable quality and compliance for programs/portfolio across Japan Research & development Division
• Serve as the quality expert for global/systemic clinical quality issue investigations, which includes:
• Be accountable for leading PMDA inspection readiness for assigned programs/portfolio including but not limited to:
etc.
- 応募資格
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- 必須
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Qualifications
• 10 or more years experience in GCP and quality assurance in tactical capacities
• Established expertise and training in GxP systems. Extensive knowledge of global regulations and standards.
• Significant experience with GxP investigations, risk assessments and CAPA management
• Experience participating in regulatory inspections
• Functional planning experience and ability to develop functional vision, priorities and tactics
• Experience with multinational products and regulations as well as with mandated risk management plans
Education
• Bachelor’s degree in life science required. Advanced degree strongly preferred.
- 雇用形態
- 正社員
- 勤務地
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東京都
在宅勤務制度あり
- 勤務時間
- フルフレックス制度
- 年収・給与
- 想定年収：1200万円～1400万円程度（応相談）※ご経験・スキルに応じて検討します。
- 待遇・福利厚生
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フルフレックス制度
在宅勤務制度（週2回）
社会保険完備
- 休日休暇
- 完全週休二日制（土曜、日曜、祝日）、年末年始休暇、年次有給休暇
