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Senior Quality Engineering Architect
1 month ago
Genmab is a pioneering biotechnology company dedicated to developing innovative antibody therapeutics that transform the lives of patients with cancer and other serious diseases. Our team is passionate about leveraging cutting-edge technology and translational research to create next-generation antibody medicines.
The RoleWe are seeking a highly skilled Senior Quality Engineering Architect to join our team in Copenhagen. As a key member of our Quality Engineering team, you will be responsible for designing, implementing, and overseeing the validation and testing architectures for our extensive portfolio of research and clinical development platforms.
Key Responsibilities- Design and deliver test strategies specifically tailored for AI/ML products, Data Engineering solutions, Data-as-a-Product, and SaaS offerings.
- Develop and enhance automated test frameworks, covering AI models to data-driven UI 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 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.
- 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.
At Genmab, you will be part of a dynamic and innovative team that is committed to making a meaningful impact in the lives of patients. We offer a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development.
About You- You are passionate about our mission to transform the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do.
- You are a generous collaborator who can work in teams with diverse backgrounds.
- You are determined to do and be your best and take pride in enabling the best work of others on the team.
- You are not afraid to grapple with the unknown and be innovative.
- You have experience working in a fast-growing, dynamic company (or a strong desire to).
- You work hard and are not afraid to have a little fun while you do so.
