|部署・役職名||Associate Director, Clinical QA － Japan / Asia Pacific|
Reporting to the Executive Director of Clinical Quality Assurance, the Associate Director of Clinical Quality Assurance for Japan / Asia Pacific region serves as a strategic partner in managing quality and regulatory compliance related to Good Clinical Practices （GCP）, Good Pharmacovigilance Practices （GVP）, and other related activities performed by Medical/Clinical Departments in the Japan / Asia Pacific region. The incumbent will provide support and promote collaboration internally to ensure all systems, processes and their outcomes comply with applicable international, regional and national standards, regulations and guidelines.
Responsibilities will include, but are not limited to, the following:
• Full understanding of and practical experience establishing and fostering compliance with global ICH E－6 Good Clinical Practice and practical knowledge of Good Pharmacovigilance Practice and Good Laboratory Practice.
• Full understanding of and practical experience with Japan / Asia Pacific GCP regulations and practical knowledge of regional GVP.
• Establish and maintain GCP/GVP inspection readiness and act as the company’s representative during regulatory agency inspections and vendor audits in the region.
• Establish and maintain inspection readiness of clinical vendors, investigator sites and external contract organizations in the region.
• Responsible for quality assurance program in supporting GCP/GVP activities; this includes overseeing and assisting with training and auditing programs, development and review of SOPs/WIs （global/regional/local）, conducting vendor and site audits, as well as writing and reviewing QEs/CAPAs in the region.
• Foster a risk－based and scientific－based quality system to support GCP/GVP.
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• Organize and conduct internal clinical system process audits, global and regional.
• Utilizes a quality system approach to ensure all GCP/GVP operations are in compliance, while maintaining an efficient workflow to facilitate operational excellence.
• Contribute to operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas.
• Partner with colleagues in Clinical, Pharmacovigilance, Regulatory, and Medical departments to increase the overall effectiveness of the Quality role and instill a Quality Improvement approach in all activities.
【必須（MUST）】• At least 6 years of clinical development experience in the pharmaceutical/biotech Industry including clinical study experience
• Experience in Global, cross－functional team environment
• Experience in respiratory, infectious disease and/or immunology areas are preferable
• Experience in CRO, vendor and laboratory selection and oversight are required.
• Experience in the management across a development program and participation in JNDA filing is preferred.
• Basic knowledge of the pulmonary therapeutic area
• Working knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies
Please note that only qualified candidates will be contacted.