About Genmab’s IT & Digital Organization:   

Join Genmab IT & Digital in transforming patient care through innovative technology solutions. We are looking for a skilled Quality Engineering Architect to drive the automation and enhancement of GxP workflows across our supported products and platforms, focusing on life sciences' critical environments.  

The Role

As a Senior Quality Engineering Architect at Genmab, 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.   

This role is hybrid which means that you will be working min. 60% of the time onsite in our HQ in Valby, Copenhagen, Denmark.

Key Responsibilities

• Design and deliver test strategies specifically tailored for AI/ML products, Data Engineering solutions, Data-as-a-Product and SaaS offerings like e.g. Drug Supply IRT Systems. 

• Develop and enhance automated test frameworks, covering from 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 Masters.   

• 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.  

Certifications (Desirable):  

• ISTQB, PMP, ISEB, SAFE, AWS, AZURE, TOSCA, QAI, CSQE  

Skills

• Hands-on experience with test automation tools and frameworks such as Tricentis Tosca, Selenium and Cucumber and other automated data validation frameworks.  

• Proficient in Database, data validation and data quality validation 

• Experience with OpenAI LLM, APIs, AI prompting and HCP narratives and the use of e.g. OpenAI automated validation framework 

• Experience with data management, architecture e.g. datalake, rationalDB and data integrations and the use of e.g. IICS and IDMC 

• Experience with build and CI/CD tools like Gitlab, Jenkins, TeamCity, and Maven.  

• Familiarity with Agile SDLC in a product-based operating model, including sprint planning, ceremonies, traceability etc 

• Proficient with API/web services testing using tools like Postman, SoapUI, and Ready API.  

• Strong background in Security testing, virtualization technologies, and containerization.  

• Knowledge about system integration and cloud service architecture, such as Gitlab plug-ins to selenium and data lakes (AWS and Azure)  

Experience

• Minimum 7 years in OO software development/architecture, preferably Java or alike.  

• Extensive experience in automated testing and expertise with commercial tools like Tosca, Appium, Selenium or any value adding Open Source 

• Experience with orchestration engines, workflows, RPA, BPMN, and mocking frameworks is highly advantageous.  

• Experience from pharmaceutical industry and familiar with GxP Testing and Validation frameworks and methodologies. 

Why 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.  

Join Genmab and be at the forefront of creating an impact where it matters most.