System Compliance Specialist

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

At Genmab, we are seeking a skilled System Compliance Manager to join our Digital Systems Management team. The successful candidate will be responsible for ensuring the compliance of our enterprise electronic document management system, GenDocs, which supports daily operations in our dynamic and expanding R&D organization.

The ideal candidate will have extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management. They will be responsible for improving and developing the IT compliance of the GenDocs system and the associated business and administration processes around the system.

Key Responsibilities:

  • Maintain the system compliance documentation during operation of GenDocs.
  • Lead and conduct periodic review and other periodic compliance activities.
  • Have oversight of vendor compliance documents.
  • Liaise with QA, Legal, IT and other Genmab departments to ensure implementation of compliance requirements.
  • Develop and optimize system processes for the operation and maintenance of the GenDocs system.
  • Participate in future Veeva Vault projects as Validation Lead/SME.

Requirements

  • Bachelor's degree in Life Science, IT, Engineering or similar area.
  • At least 5 years of work experience from the pharmaceutical or biotech industry.
  • Extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management.
  • Practical work experience with EDMS systems.

About You

  • Passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • Bring rigor and excellence to all that you do.
  • Strong collaborator who can work in teams with diverse backgrounds.


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