Overall job objectives
This position is responsible to:
- Collaborate with stakeholders within R&D PV QA, as well as outside of R&D PV QA, such as procurement, finance, legal (as applicable), R&D, Clinical Safety and Pharmacovigilance (CSPV), Medical Affairs, Market Access, Non-clinical Research, and IT to ensure consistent implementation of the GxP vendor quality program across Daiichi Sankyo group companies.
- Continuously assess existing practices and identify areas that need refinement and/or areas to archive a fit-for-purpose GxP vendor quality program in the Daiichi Sankyo group.
- Ensure that GxP vendor qualification status is current, periodically review the risk category of all existing GxP vendors, and prioritize them to be included in the Master Audit Schedule for the subsequent fiscal year.
- Collaborate with stakeholders within R&D PV QA, Legal, and business functions to ensure QA agreements are established for all critical GxP vendors.
Core responsibilities
- Vendor Qualification and Management
- Lead the qualification process for new GxP vendors, including Contract Research Organizations (CROs), Clinical Laboratories, GLP Laboratories, GxP IT computerized system/software vendors, Pharmacovigilance (PV) third parties, etc.
- Conduct risk-based assessments and evaluations of vendors to ensure compliance with regulatory requirements and internal company standards.
- Manage the approved global vendor list and ensure all vendors are qualified, approved, and monitored according to company policies.
- Vendor Audit and Inspection Support:
- Provide input from an audit focus area perspective to Audit & Compliance during the vendor audit planning stage.
- Act as a Subject Matter Expert (SME) for vendor quality and provide support to the inspection management team before, during, and after the audit and regulatory inspection.
- Compliance and Documentation
- Develop and maintain vendor-related quality agreements, ensuring clear roles and responsibilities for GxP compliance are established.
- Ensure proper documentation of all vendor quality activities, including qualification records, and risk assessments.
- Monitor vendor quality performance through Key Performance Indicators (KPIs) and Quality Metrics, providing regular reports to senior management.
- Cross-Functional Collaboration
- Collaborate with internal stakeholders, including business functions, procurement and legal to align on vendor quality requirement.
- Support the resolution of vendor-related issues that impact quality, data integrity and scientific integrity, timelines or compliance.
- Continuous Improvement
- Lead continuous improvement initiatives related to vendor quality management processes.
- Stay current with industry best practices, regulatory changes, and trends in GxP compliance, and implement changes to maintain an industry-leading vendor quality program.
