Validation Lead Manager

3 weeks ago


San Francisco, California, United States Daiichi Sankyo, Inc. Full time
Job Title: Validation Lead Manager

About the Role:

We are seeking a highly skilled Validation Lead Manager to join our team at Daiichi Sankyo, Inc. As a key member of our Global DX Computer System Validation team, you will be responsible for managing global CSV projects, ensuring compliance with global regulatory and Daiichi Sankyo requirements, and business expectations.

Key Responsibilities:

  • Manage Global DX Computer System Validation (CSV) projects, ensuring compliance with global regulatory and Daiichi Sankyo requirements.
  • Execute the Global DX Computer System Validation methodology to determine the amount of system validation or qualification needed to achieve and maintain regulatory compliance.
  • Contribute to the Daiichi Sankyo validation strategy, considering regulatory requirements, industry best practices, and company policies and procedures.
  • Provide expertise and solutions to CSV questions and issues.

Requirements:

  • Minimum of a Bachelor's degree in physical, life, or computer sciences.
  • Five or more years' experience with a world-class quality organization.
  • First-hand knowledge of GAMP5, GxP, and Non-GxP computer system validation and qualification, and Computer Software Assurance (CSA).
  • Direct dealings with FDA, EMA, PMRA, or other regulatory agencies.
  • Strong appreciation of the impact of regulatory bodies on pharmaceutical operations.

Travel:

Ability to travel up to 10% to Europe, Japan, and other DS locations.

About Daiichi Sankyo, Inc.:

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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