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

Job Summary

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.

Responsibilities

• 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
• Develop, review, and maintain 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.

Qualifications

• Education
• Bachelor's Degree in Life Sciences, Pharmacy or related field required.
• An advanced degree (Master's or higher strongly preferred).
• Experience
• 4 or more years of professional experience and/or relevant experience in Quality Assurance and/or Clinical Development within the pharmaceutical, biotechnology, or medical device industry required.
• Candidate must have experience supporting GCP/GLP/GVP vendor or supplier quality management & oversight.
• Must have demonstrated experience in the execution and management of GCP/GLP/GVP vendor qualification, audit, and monitoring programs, applying a risk based approach.
• Support of regulatory inspections and health authority interactions is preferred.
• In depth knowledge of international GxP regulations and guidance, including FDA, EMA, PMDA, NMPA, MFDS, ICH, GDPR, GAMP 5, and 21 CFR Part 11, with practical experience in Computerized System Validation (CSV) preferred.
• Experience in CAPA management and QMS implementation, maintenance, and continuous improvement.
• Manage work effectively in a global, hybrid working environment.
• Must have exposure to Clinical Development, Clinical Operations, Pharmacovigilance, Medical Affairs, and vendor managed services.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Familiar with AI tools (e.g., ChatGPT, DeepSeek, Microsoft Copilot), with the ability to create effective prompts for quality search and business outputs is preferred.

Salary Range

USD$127,280.00 - USD$190,920.00