System Management Professional

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About the Job

  • This exciting opportunity allows you to bring your expertise in IT compliance to a cutting-edge EDMS system, supporting the growth of our dynamic R&D organization.
  • You will collaborate closely with our cross-functional teams to develop and optimize system processes, ensuring seamless operation and compliance with GxP regulations.

Responsibilities:

Key Responsibilities
  • Maintain accurate and up-to-date system compliance documentation.
  • Lead and conduct regular reviews to ensure ongoing compliance and identify potential issues.
  • Liaise with internal stakeholders to implement compliance requirements impacting the system.
  • Develop and optimize system processes to improve efficiency and effectiveness.
  • Participate in Veeva Vault projects as Validation Lead/SME, ensuring compliance and quality standards are met.

Requirements

  • You have a bachelor's degree in a relevant field, such as Life Science, IT, or Engineering.
  • At least 5 years of experience in the pharmaceutical or biotech industry, with 1-2 years in a similar role.
  • Extensive knowledge of GxP systems, GAMP, IT validation, and test management.
  • Prior experience with EDMS systems and Veeva Vault administration is highly desirable.

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