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

Location: Basking Ridge

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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.

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. 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 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.

Responsibilities Continued Qualifications Education Qualifications Bachelor's Degree Bachelor's degree in Life Sciences, Pharmacy or related field required. An advanced degree (Master's or higher strongly preferred) Experience Qualifications 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 experiene 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, Deep Seek, Microsoft Copilot), with the ability to create effective prompts for quality search and business outputs is preferred.

Experience with Sparta Track Wise eQMS System is preferred. Travel Requirements Ability to travel up to 10% of the time both domestic and international…