Senior Quality Engineering Architect

4 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time

Transforming Patient Care through Innovative Technology Solutions

At Genmab, we're committed to developing groundbreaking solutions that empower healthcare transformation. As a Senior Quality Engineering Architect, you will play a pivotal role in driving the automation and enhancement of GxP workflows across our supported products and platforms.

About Our IT & Digital Organization

Our team is dedicated to harnessing the power of technology to revolutionize patient care. We're seeking a skilled professional to join our mission and contribute to the design, implementation, and oversight of validation and testing architectures for our research and clinical development platforms.

The Role

You will be instrumental 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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