Quality Assurance Systems Architect Manager

3 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

About the Company

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.

We are committed to fostering workplace diversity at all levels of the company and believe it is essential for our continued success.

Key Responsibilities:

  • Design test strategies tailored for AI/ML products, Data Engineering solutions, and SaaS offerings.
  • Implement RPA, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) within the Test Validation Framework.
  • Collaborate cross-functionally with IT teams, DS/AI, and business stakeholders to define and improve test strategies, frameworks, infrastructure, tools, and coverage.

Qualifications

  • Bachelor's degree in computer science, Engineering, Information Systems, or a related field.
  • Proven experience in a solution automation architect role, preferably within a GxP-regulated Life Sciences environment.
  • GxP validation experience with key regulatory requirements such as 21 CFR Part 11, EU Annex 11.


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