Senior Quality Engineering Architect, R&D Research Expert

1 month ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Company Overview
Genmab is a pioneering biotechnology company committed to developing innovative antibody therapeutics. With a strong focus on translational research and data sciences, Genmab has established itself as a leader in the industry.

About Us
We are passionate about our purpose of transforming lives through cancer treatment. Our commitment to excellence drives us to strive for rigor and innovation in everything we do.

The Role
We are seeking a skilled Senior Quality Engineering Architect to join our team. As a key member of our IT & Digital organization, you will play a critical role in 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 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.
- 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.

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.

Salary Range
This position offers an estimated salary range of $120,000-$180,000 per year, based on location and level of experience.

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