Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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
This position provides leadership and oversight for implementation of DSI’s GxP computer system validation (CSV) lifecycle and related QA-CSV strategies, providing oversight and guidance for compliance with Daiichi Sankyo expectations, business and regulatory requirements and industry best practices. This position interacts within Quality Assurance sub-functional and cross-functional teams, vendors and consultants, and leads the supporting QA-CSV outside service resources. This position participates in global GxP-CSV projects and contributes to or participates in global computer system validation working groups. Additionally, this position leads or participates in the QA-CSV vendor audit program.* This position solves problems and makes decisions according to established guidelines, regulations, DS procedures and experience, and makes some strategic decisions; escalates issues to management as necessary. As required by business needs, this position performs specific tasks across other QA-CSV levels.
Responsibilities
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)
Experience Qualifications
Travel
Ability to travel up to 30% On-site support/meetings at various Daiichi Sankyo and vendor locations as necessary.
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.
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