Senior Quality Engineering Architect, R&D Research & Drug Development

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

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.   

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.  

About You

• You are passionate about our purpose and genuinely care 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 fierce believer in our rooted-in-science approach to problem-solving
• 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

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. 

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. 

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website https://www.genmab.com/privacy.

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.