Top Quality Assurance Architect for Innovative Life Sciences

4 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We are seeking a skilled Quality Assurance Architect to join our team at Genmab, a pioneering biotechnology company dedicated to developing innovative antibody therapeutics. This is an exciting opportunity to drive the automation and enhancement of GxP workflows across our supported products and platforms, focusing on life sciences' critical environments.

As a Senior Quality Assurance Architect, you will be instrumental in designing, implementing, and overseeing the validation and testing architectures for our extensive portfolio of research and clinical development platforms. This includes but is not limited to Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), Zontal SDMS, Genedata BioPharma, Clinical Trial Management Systems (CTMS), Drug Supply IRT Systems, Electronic Trial Master Files (eTMF), Quality Document Management Systems, Cloud data lakes (AWS), Medidata EDC Rave, and our Pathology/Pharmacology/pharmacovigilance platforms, such as Oracle Argus.

Key Responsibilities
  • Design and deliver test strategies specifically tailored for AI/ML products, Data Engineering solutions, Data-as-a-Product, and SaaS offerings like Drug Supply IRT Systems.
  • Develop and enhance automated test frameworks, covering AI models to data-driven UI frameworks using tools like Tosca, Selenium, and CI/CD pipelines using tools such as Groovy, Ant, Shell scripting, Ready API, Maven, NodeJS, Bash scripting, and Fortify.
  • Design and Implement RPA.
  • Implement Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) within the Test Validation Framework to ensure compliance and integration in product releases.
  • Collaborate cross-functionally with IT teams, DS/AI, and business stakeholders to define and improve test strategies, frameworks, infrastructure, tools, and coverage.
  • Lead the documentation and tracking of defects using tools like JIRA, Xray, or HP ALM.
  • Conduct research and analysis to select appropriate tools, automation frameworks, and methodologies for improving testing processes.
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.
  • Familiarity with XML, Java libraries/frameworks such as CXF, JAXB, and Spring.
Estimated Salary: $130,000 - $160,000 per yearWhy Join Us?

At Genmab, you will be part of a pioneering team dedicated to developing innovative solutions that empower healthcare transformation. You will work in a challenging and rewarding environment where your contributions directly influence patient outcomes. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth.



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