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

Daiichi Sankyo US; Basking Ridge (NJ); On-site; USD 127,280 - 190,920; Full time

Job summary

Daiichi Sankyo US is seeking a Manager, Global Vendor Quality (Global R&D & PV QA) to lead the vendor quality program across the Daiichi Sankyo group companies. You will partner with R&D & PV QA, Procurement, Legal, CSPV, Medical Affairs, and other functions to ensure qualification, oversight, and regulatory compliance.

The role emphasizes operational execution, continuous improvement, and subject-matter expertise under senior leadership.

Qualifications

• 4+ years of QA/Clinical Development experience in pharma/biotech/medical devices.
• Experience with GCP/GLP/GVP vendor qualification, audit, and monitoring.
• Knowledge of international GxP regulations (FDA, EMA, ICH, GDPR).
• Capable of working in a global, hybrid environment and travel up to 10%.

Responsibilities

• Lead vendor qualification and risk-based assessments for CROs and GxP vendors.
• Support vendor audits and participate as auditor or team member.
• Assist in regulatory inspections and CAPA follow-up.
• Develop and maintain vendor quality agreements with Legal, Procurement, and stakeholders.
• Track vendor quality metrics and report trends for management.
• Collaborate cross-functionally to align vendor quality with regulatory needs.

Skills

GxP vendor quality management

Quality Assurance

Regulatory compliance

Cross-functional collaboration

Audit & inspection support

2-3% AI tool familiarity

Education

Bachelor's degree in Life Sciences/Pharmacy

Advanced degree (Master's or higher)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Sparta TrackWise eQMS

Job description

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.

Qualifications

• Education Qualifications
  • 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 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.
  • Experience with Sparta TrackWise eQMS System is preferred.
• Travel Requirements
  • Ability to travel up to 10% of the time both domestic and international.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range

USD$127,280.00 - USD$190,920.00