Digital Systems Compliance Lead for Electronic Document Management

14 hours ago


Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're committed to building extraordinary futures together by developing innovative antibody products and pioneering therapies that transform the lives of patients and change the course of cancer treatment and serious diseases.

The Role

Genmab is seeking a highly skilled Digital Systems Compliance Lead to oversee the IT compliance of our enterprise electronic document management system (EDMS), GenDocs, covering clinical development, regulatory affairs, CMC, and QA areas in R&D. 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 Digital Systems Compliance Lead, you will be responsible for improving and developing the IT compliance of the GenDocs system and associated business and administration processes. This will involve collaborating with the team to update system-related documentation, conducting periodic reviews, investigating issues or new requirements, and participating in new Veeva projects as Validation Lead/SME.

Key responsibilities include:

  • Maintaining system compliance documentation during EDMS operation;
  • Leading and conducting periodic review and other compliance activities;
  • Oversight of vendor compliance documents;
  • Liaising with QA, Legal, IT, and other Genmab departments to ensure implementation of compliance requirements;
  • Developing and optimizing system processes for EDMS operation and maintenance;
  • Participating in future Veeva Vault projects as Validation Lead/SME;
  • Developing and optimizing IT validation procedures and tools in the team;
  • System configuration or issue-related system administration work in the team;
  • Preparing, coordinating, and participating in audits and inspections of the EDMS system.

Requirements

We are looking for an individual with a bachelor's degree in Life Science, IT, Engineering, or similar area, and at least 5 years of work experience from the pharmaceutical or biotech industry, including 1-2 years' experience in a similar role.

Key qualifications include:

  • Extensive knowledge and understanding of GxP systems, GAMP, IT validation, and test management;
  • Participation in IT GxP projects as project SME or Validation Lead;
  • Practical work experience with EDMS systems and preferably Veeva Vault administrator and platform certification;
  • Excellent communication skills in English, written and oral.

About You

As a passionate advocate for our purpose, you genuinely care about transforming the lives of patients through innovative cancer treatment. You bring rigor and excellence to all your endeavors, believing in our rooted-in-science approach to problem-solving.

Key personal qualities include:

  • Ability to work independently as well as in teams;
  • Service-minded and meeting challenges with a positive mindset;
  • Pragmatic attitude, balancing different perspectives;
  • Take responsibility and have a personal drive;
  • Structured and systematic, adapting to the context.

Location

Genmab leverages the effectiveness of an agile working environment for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that connect employees while being immersed in our state-of-the-art laboratories.



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