Quality Assurance Expert Leader

2 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

Pioneering Therapies that Change Lives

Genmab is an international biotechnology company committed to developing innovative antibody therapeutics that transform the lives of patients. As a Senior Quality Engineering Architect, you will be part of a pioneering team dedicated to harnessing the power of technology to revolutionize patient care.

About Our Mission

We are driven by a passion to develop next-generation antibody technology platforms and leverage translational research and data sciences to create novel therapies. Our team is committed to pushing the boundaries of what is possible in the pursuit of improving patient outcomes.

The Role

You will play a critical role in designing and delivering test strategies tailored for AI/ML products, Data Engineering solutions, and SaaS offerings like Drug Supply IRT Systems. Your expertise will drive the development and enhancement of automated test frameworks using tools like Tosca, Selenium, and CI/CD pipelines.

Key Responsibilities

  • Design and deliver test strategies specifically tailored for AI/ML products, Data Engineering solutions, and SaaS offerings
  • Develop and enhance automated test frameworks using tools like Tosca, Selenium, and CI/CD pipelines
  • Design and implement RPA
  • Implement 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, preferably a Master's
  • Proven experience in a solution automation architect role, preferably within a GxP-regulated Life Sciences environment and GLP
  • GxP validation experience with key regulatory requirements such as 21 CFR Part 11, EU Annex 11
  • Expertise in relational databases, data management, and performance SQL scripting


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