Digital Systems Compliance Specialist

1 day ago


Copenhagen, Copenhagen, Denmark Genmab Full time

We are seeking a Digital Systems Compliance Specialist to join our team at Genmab, a global biotech company dedicated to developing innovative cancer treatments.

About the Role

The successful candidate will be responsible for maintaining system compliance documentation for our enterprise electronic document management system (EDMS), GenDocs. This involves reviewing and updating validation master plans, risk registers, and standard operating procedures.

Additionally, you will lead periodic reviews, conduct critical user reviews, and participate in audits and inspections of the GenDocs system. Your extensive knowledge of GxP systems, GAMP, IT validation, and test management will ensure seamless implementation of compliance requirements.

Responsibilities

  • Maintain and update system compliance documentation
  • Lead periodic reviews and other compliance activities
  • Review vendor compliance documents
  • Liaise with QA, Legal, IT, and other departments to ensure compliance
  • Develop and optimize system processes
  • Participate in Veeva Vault projects as Validation Lead/SME
  • Develop and optimize IT validation procedures and tools
  • Participate in system configuration or issue-related administration work
  • Prepare, coordinate, and participate in audits and inspections

Requirements

  • Bachelor's degree in Life Science, IT, Engineering, or similar field
  • 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
  • Practical experience with EDMS systems, preferably Veeva Vault administrator and platform certification
  • Excellent communication skills in English, written and oral

About You

  • You are passionate about improving patient outcomes through innovative cancer treatment
  • You bring rigor and excellence to your work, valuing a science-driven approach
  • You are a collaborative team player who can adapt to diverse backgrounds
  • You take pride in enabling high-quality work from others and are not afraid to innovate
  • You thrive in fast-paced, dynamic environments and enjoy having fun while working hard

Salary Range: $120,000 - $180,000 per year, depending on location and experience. Genmab offers an agile working environment, open community spaces, and opportunities for growth and development. Join us in shaping the future of cancer treatment



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