The Senior Manager GCP Audit will provide assurance to the Global QA GxP Audits Team that the QA GCP audits and due diligence efforts are fully functional and compliant with ICH GCP, the applicable national and international laws and guidelines and global Daiichi Sankyo written procedures. This role is responsible for the assurance to the Global Daiichi Sankyo Quality Management that all aspects of GCP regulatory inspections, vendor and clinical site by Competent Authorities / Health Authorities will be handled and managed adequately and appropriately.

Roles and responsibilities:

• Manage assigned aspects of a fully functional QA GCP audit program as assigned by the Head Global GxP audits for Daiichi Sankyo Global phase I through IV studies of clinical development and supporting discovery phase QA activities where necessary
• Manage and execute the investigator site, service provider and internal systems and process audit program to assure an all acceptable state of compliance
• Support all aspects of GCP regulatory inspections at investigator sites, CROs, vendors and sponsor facility during preparation, conduct, coordinating responses to inspections, and to ensure supporting documentation, tracking and verification of CAPA implementation
• Assure that all studies managed by DSE or are performed under DSE legal responsibility are in compliance with GCP requirements and can withstand scrutiny from regulators in all countries where Daiichi Sankyo conducts clinical trials 
• Manage metrics and the implementation tracking of corrective and preventive actions as follow-up to audits and inspections
• Work with Daiichi Sankyo Japan, Daiichi Sankyo USA and other Daiichi Sankyo QA groups in developing and implementing QA GCP objectives and audit schedules with regards to development related audits of CROs, investigator sites, bioanalytical labs, etc.
• Collaborate and represent the Global QA group in conducting joint audits and global SOP development. Liaise and consult with Early and Late Strategy, Development Teams, Pharmacovigilance, Operational and Technical Services and others to ensure local and global compliance with regulatory requirements, good clinical practice, internal standards, and to provide pro-active integration of quality and process improvement