Manager, Global Vendor Quality, Global R&D & PV QA

The Manager, Global Vendor Quality (Global R&D & PV QA) supports the development, implementation, and execution of the GCP/GLP/GVP vendor quality program across Daiichi Sankyo group companies. The role partners closely with internal stakeholders within R&D & PV QA and cross-functionally (e.g. Procurement, Legal, CSPV, Medical Affairs, Non-clinical Research, IT) to ensure vendor qualification, oversight, and compliance activities are performed in accordance with regulatory requirements and internal standards. This position focuses on operational execution, oversight, and continuous improvement of vendor quality activities, contributing subject-matter expertise while working under the direction of senior vendor quality leadership.

Vendor Qualification and Management
Execute the qualification process for new and existing GxP vendors (e.g. CROs, Clinical and GLP laboratories, PV service providers, GxP IT/computerized system vendors).
Perform and document risk-based vendor assessments in alignment with internal procedures and global regulatory expectations.
Maintain vendor qualification status and support periodic vendor risk categorization updates.
Support maintenance of the global approved vendor list in accordance with company policies and quality system requirements. Vendor Audit and Inspection Support
Provide vendor quality input to Audit & Compliance for risk-based vendor audit planning.
Participate in vendor audits as an auditor or audit team member, as assigned.
Act as a subject matter expert for vendor quality during regulatory inspections and internal audits, supporting preparation, conduct, and follow-up activities. Compliance and Documentation
Support development, review, and maintenance of vendor-related quality agreements in collaboration with Legal, Procurement, and business stakeholders.
Ensure accurate and timely documentation of vendor qualification, oversight, and performance monitoring activities.
Track vendor quality performance metrics and contribute to routine reporting and trending reviews for management oversight. Cross-Functional Collaboration
Collaborate effectively with internal stakeholders to align vendor quality requirements with business and regulatory needs.
Support investigation and resolution of vendor-related quality events, data integrity issues, deviations, and CAPAs impacting compliance or timelines.
Communicate vendor quality risks and issues clearly to relevant stakeholders and vendor quality leadership. Support Continuous Improvement
Contribute to continuous improvement initiatives related to vendor quality processes, tools, and metrics.
Support implementation of updates to procedures, templates, and systems related to vendor quality management.