Responsibility for end-to-end audit activities of RDPV QA relevant audit activities for the Daiichi Sankyo Group and its partners as applicable. Ensures the execution of a risk-based audit program and effective CAPA management resulting from audits, health authority inspections; manages audit planning, assignments, support, and reporting of Clinical Research and Development (GCP) and Postmarketing audits/inspections across the organization and affiliates as appropriate for the area of audits assigned.

Roles and Responsibilities:

Manage and coordinate the audit program for clinical studies and vendors, as applicable, within the assigned RDPVQA audit areas, in alignment with the Master Audit Schedule by:

• Applying a risk-based approach to ensure Audit Plans are aligned with company strategy, objectives, and regulatory requirements.
• Maintaining and adjusting Audit Plans, as needed, to support evolving business priorities and internal and external stakeholder needs.
• Effectively planning, coordinating, and executing audits to ensure the audit program meets applicable regulatory and quality requirements.
• Performing audits to assess compliance with GxP and company standards, identifying compliance issues, systemic gaps, and emerging trends.
• Communicating audit outcomes and recommendations to stakeholders and supporting the implementation and monitoring of corrective and preventive actions (CAPAs).
• Monitoring audit metrics and trends to drive continuous improvement and strengthen the effectiveness of the quality management system.
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