Associate Director Global Applications & Services (Validation Lead)

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

The Validation Lead will manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo for Computerized Systems supporting GxP activities, assuring that these systems are compliant with global regulatory requirements, Daiichi Sankyo requirements, and business expectations. This role must execute the Global DX SDLC and CSV methodologies to determine the amount of system validation or qualification needed to achieve and maintain regulatory compliance, regardless of service solutions (SaaS, On-Prem, Service Provider Outsourcing) throughout a system's lifecycle. Additionally, this role will contribute to the Daiichi Sankyo SDLC and validation strategy by considering regulatory requirements, industry best practices, and company policies and procedures. Finally, the Validation Lead is a forward-thinking innovator and provides expertise and solutions to CSV questions and issues as they arise.

Responsibilities

• Provide validation leadership and strategic oversight for Daiichi Sankyo GxP computer system implementations and upgrades, collaborating with Business, IT, and Global QA Senior Leadership. Partner with Global DX and QA-CSV/eCompliance teams to drive the compliant, efficient, and timely execution of global DX GxP CSV projects.
• Develop and define validation activities, timelines, and resource requirements for GxP global CSV projects. Collaborate cross-functionally to align project deliverables with organizational priorities and regulatory expectations.
• Provide strategic guidance and leadership in the change management process for GxP global validated systems where necessary. Champion the adoption and execution of a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business needs.
• Oversee and/or execute the regulatory-compliant computer system validation or qualification of global GxP and Non-GxP computer systems, driving operational excellence and adherence to regulatory standards.
• Maintain effective communication with project stakeholders. Provide oversight to assure that all validation work performed for Daiichi Sankyo by various contractors meets Global DX Procedures, Computer System Validation requirements, global regulatory compliance, and global quality expectations.
• Partner with global quality departments to review global policies, inspections, audit CAPAs, and vendor audit documentation.
• Oversee the creation and review of various validation documentation such as Validation Plans, User/Functional Requirement specifications, Protocols (IQ/OQ/PQ), Test Scripts, and Summary Reports ensuring alignment with regulatory guidelines and organizational goals.
• Collaborate cross-functionally with IT, Business, and QA Leadership to drive best practices and continuous improvement in validation processes.
• Lead and support the development, maintenance, and enhancement of Global DX Computer System Validation policies and procedures in collaboration with global DX and global quality departments. Ensure alignment with evolving regulatory expectations and organizational goals.
• Drive the evaluation of key performance indicators and spearhead initiatives for process improvement. Lead SDLC Lessons Learned sessions to identify opportunities for enhancing validation efficiency, implementing best practices, and measuring key success factors to achieve organizational excellence.
• Collaborate with IT and QA leadership to establish and implement industry-leading CSV best practices for the assessment and validation of AI-driven support projects, ensuring compliance, efficiency, and regulatory alignment.
• Drive continuous improvement and maintain current knowledge of cGMP regulatory issues, Good Automated Manufacturing Practices (GAMP5), and Good Practices Guides, Risk-Based Approach/Computer Software Assurance (RBA/CSA) to assure related Daiichi Sankyo business needs are met.
• Maintain the Global DX global validation methodology in accordance with current regulatory guidelines.
• Provide appropriate training and guidance on global DX computer system validation procedures and policies to Daiichi Sankyo employees and contractors/consultants involved with GxP computerized system validation and/or usage to assure an understanding of, and compliance with, Daiichi Sankyo requirements.
  
  
  

Qualifications

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications

(from an accredited college or university)

• Bachelor's Degree: Bachelor's degree in Physical, Life, or Computer Science or related field. (Required)
  
  
  

Experience Qualifications

• 7 or More Years: 7 or more years of relevant experience with a world-class quality organization. (Required)
• First-hand knowledge of GAMP5, GxP, and Non-GxP computer system validation and qualification, and Computer Software Assurance (CSA), SDLC related to pharmaceutical operations. (Preferred)
• Direct dealings with FDA, EMA, PMRA, and other regulatory agencies. (Preferred)
• Strong appreciation of the impact of regulatory bodies on pharmaceutical operations. (Preferred)
• Experience auditing software vendors is preferred. (Preferred)
• International experience preferred; at a minimum, experience working with diverse cultures and employees is required. (Preferred)
  
  
  

Travel

• Ability to travel up to 10%. Ability to travel to the US, EU, and Japan.
  
  
  

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.