Digital Systems Compliance Expert

5 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About Genmab

  • We're a global biotechnology company dedicated to transforming lives through innovative cancer treatment.
  • Our team of passionate experts is driven by a shared purpose: improving the lives of patients worldwide.

Job Description:

The Role

As a System Compliance Manager in our Digital Systems Management team, you will play a key role in ensuring the IT compliance of our enterprise electronic document management system (EDMS) – GenDocs. This system supports daily operations in our dynamic and expanding R&D organization, covering clinical development, regulatory affairs, CMC, and QA areas.

Your primary responsibilities will include maintaining system compliance documentation during operation of GenDocs, leading and conducting periodic review and other compliance activities, reviewing vendor compliance documents, liaising with QA, Legal, IT, and other departments, developing and optimizing system processes, participating in Veeva Vault projects as Validation Lead/SME, and preparing for audits and inspections.

You will also be involved in system management work, such as configuring, implementing, and validating new system features to ensure your knowledge and skills are continuously maintained.



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