WHAT YOU WILL DO
Let's do this. Let's change the world. In this vital role you will report to the Associate Vice President, Clinical & Research Quality (CRQ). The Clinical Quality Japan Lead provides proactive end to end quality oversight strategies for the development and implementation of a customized risk-based quality assurance strategy for the clinical development program within Japan.
The Clinical Quality Japan Lead will manage end to end Quality Oversight for all Japan regional trials, and all associated suppliers/vendors operating within Japan. The Clinical Quality Japan Lead is responsible for implementing a risk-based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals). In addition, the Japan Lead will form a partnership with the Research Quality Leadership Team and all key stakeholders across Global Development to ensure that all global and regional quality standards are maintained.
This is a vital role who will develop a deep knowledge of the Japan market and Amgen's clinical development strategy. This role also provides oversight and quality management of critical data and processes for local study teams, the local clinical trial sites, and all associated suppliers/vendors that operate in Japan.
RESPONSIBILITIES
- Review Japan specific clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
- Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
- Provide oversight for the development and implementation of Quality Plans specifically suited for Japan
- Establish regional and country level expertise within Japan to ensure quality and compliance to local regulations
- Liaise with the Clinical Quality Therapeutic Leads to support TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
- Collaborate on TA-specific Quality Assurance plans for application in Japan, so that they are fit for purpose, risk based and efficient. This includes TA specific audit plans, and the execution of audits (investigator site audits, affiliate audits, and study level audits).
- Support Japan-specific Clinical Trial Teams for all quality management activities, including Issue Management (e.g., Deviations/CAPAs and Serious Breaches/ Privacy Issues), Inspection Readiness activities, and Inspection Management activities
- Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods).
WIN
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills, and has these qualifications:
- 5 years or more experience in Quality Management , Quality Assurance , or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
- Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise.
- Thorough understanding of Clinical R&D activities and Global Regulations, and Japan-Asia Pacific Regulations
- Knowledge of the Regulatory Submission and Inspection Management procedures in the Asia Pacific Region.
- Quality Oversight of Clinical Trials , including clinical trial protocol development, execution, and submissions.
- People leadership and managerial expertise.
- Excellent verbal and written communication skills, including strong business writing abilities and active listening.
- Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format.
- Strong analytical, critical-thinking, and decision-making abilities.
- Capability to understand and articulate technical concepts and literature in spoken and written English .
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