Senior Compliance Expert for Digital Systems Management

6 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About the Role

We are seeking a Senior Compliance Expert to join our Digital Systems Management team at Genmab. As a key member of our team, you will play a vital role in ensuring the IT compliance of our electronic document management system (EDMS) – GenDocs.

GenDocs is a global IT system based on the Veeva Vault cloud platform, supporting daily operations in our dynamic and expanding R&D organization. As a Senior Compliance Expert, you will be responsible for maintaining the system compliance documentation, leading periodic reviews, and conducting audits to ensure compliance with regulatory requirements.

You will work closely with our QA, Legal, and IT departments to implement compliance requirements impacting the systems. Your expertise will also be essential in developing and optimizing system processes for the operation and maintenance of the GenDocs system.

This is an excellent opportunity to join a fast-growing, dynamic company like Genmab, where you can utilize your knowledge and skills to drive innovation and excellence in IT compliance.

About You

  • You have a bachelor's degree in Life Science, IT, Engineering, or a similar field.
  • You have at least 5 years of work experience from the pharmaceutical or biotech industry, and 1-2 years' experience from a similar role.
  • You have extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management.
  • You have practical work experience with EDMS systems, and preferably Veeva Vault administrator and platform certification.
  • You have excellent communication skills in English, written and oral.

What We Offer

We offer a competitive salary of $95,000 per year, commensurate with experience. Additionally, you will have access to our comprehensive benefits package, including health insurance, retirement plans, and paid time off.

As a valued member of our team, you will also have opportunities for professional growth and development, as well as the chance to work on cutting-edge projects that make a real difference in the lives of patients.

Location

Our offices are designed as open, community-based spaces that foster collaboration and innovation. Whether you're working remotely or in our office, you'll be part of a dynamic and supportive team that shares your passion for delivering high-quality results.



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