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Senior Quality Engineering Specialist
2 weeks ago
At Genmab, we are committed to developing innovative solutions that transform patient care. Our team is dedicated to creating extraordinary futures together by pioneering therapies that change the lives of patients and the future of cancer treatment.
About Us
We believe in being proudly unique, determined to be our best, and authentic. Our mission is to empower healthcare transformation through cutting-edge technology and science-driven approaches.
The Role
We are looking for a skilled Senior Quality Engineering Architect to drive the automation and enhancement of GxP workflows across our supported products and platforms. This includes designing, implementing, and overseeing the validation and testing architectures for our research and clinical development platforms.
Main Responsibilities
- Design test strategies 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.
- Implement Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) within the Test Validation Framework.
- Cross-functionally collaborate with IT teams 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.
- Proven experience in solution automation architect roles, preferably within GxP-regulated Life Sciences environments.
- 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.
Key Skills
- Hands-on experience with test automation tools and frameworks such as Tricentis Tosca, Selenium, and Cucumber.
- Proficient in Database, data validation, and data quality validation.
- Experience with OpenAI LLM, APIs, AI prompting, and automated validation frameworks.
- Familiarity with Agile SDLC in product-based operating models, including sprint planning and ceremonies.
Why Join Us?
At Genmab, you will be part of a dynamic team that thrives on innovation, collaboration, and mutual respect. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth.
