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

About the Role 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. This role partners with internal stakeholders (R&D & PV QA, 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. What You'll Do

• Lead and execute vendor qualification for new and existing GxP vendors (CROs, Clinical/GLP labs, PV service providers, GxP IT vendors).
• Perform risk-based vendor assessments and maintain qualification status; maintain global approved vendor list.
• Provide vendor quality input for risk-based audit planning; participate in audits as auditor or team member.
• Act as SME for vendor quality during regulatory inspections and internal audits; support prep, conduct, and follow-up.
• Develop, review, and maintain vendor quality agreements with Legal, Procurement, and stakeholders; ensure documentation of qualification, oversight, and performance monitoring.
• Track vendor quality performance metrics and contribute to regular reporting and trending for management.
• Collaborate cross-functionally to align vendor quality with business and regulatory needs.
• Investigate and resolve vendor-related quality events, data integrity issues, deviations, CAPAs affecting compliance or timelines.
• Support continuous improvement initiatives; update procedures, templates, and systems related to vendor quality management. What We're Looking For
• Bachelor’s degree in Life Sciences, Pharmacy, or related field; advanced degree (Master’s or higher) strongly preferred.
• 4+ years of professional experience in Quality Assurance and/or Clinical Development in pharmaceutical/biotech/medical device industries.
• Experience supporting GCP/GLP/GVP vendor management and oversight; risk-based qualification, audit, and monitoring programs; regulatory inspections experience preferred.
• In-depth knowledge of international GxP regulations (FDA, EMA, PMDA, NMPA, MFDS, ICH, GDPR, GAMP 5, 21 CFR Part 11); practical CSV experience preferred.
• Experience with CAPA management and QMS implementation/maintenance.
• Ability to manage work effectively in a global, hybrid environment; exposure to Clinical Development, Clinical Operations, PV, Medical Affairs, and vendor managed services.
• Proficient in Microsoft Word, Excel, PowerPoint; familiarity with AI tools (e.g., ChatGPT, DeepSeek, Microsoft Copilot) for quality search and outputs preferred.
• Experience with Sparta TrackWise eQMS system preferred.
• Domestic and international travel up to 10%. Nice to Have
• Advanced degree strongly preferred.
• Experience with AI tools and prompt engineering for QA outputs.
• TrackWise eQMS and CSV process work experience. Compensation & Benefits
• Salary Range: USD$127,280.00 - USD$190,920.00
• Download Our Benefits Summary PDF