Senior Quality Engineering Director
6 days ago
Transforming Patient Care through Innovative Solutions
Genmab IT & Digital is a pioneering team dedicated to developing cutting-edge technology solutions that empower healthcare transformation. As a Senior Quality Engineering 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.
The Role
- You will lead the design and delivery of test strategies specifically tailored for AI/ML products, Data Engineering solutions, 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.
- Cross-functionally collaborate 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.
- Familiarity with XML, Java libraries/frameworks such as CXF, JAXB, and Spring.
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