Senior Quality Engineering Architect, R&D Research
2 months ago
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Senior Quality Engineering Architect, R&D Research & Drug DevelopmentApply locations Copenhagen, Utrecht time type Full time posted on Posted 8 Days Ago job requisition id R10053
At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.
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.
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 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.
- Collaborate cross-functionally with IT teams, DS/AI, and business stakeholders.
- 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.
- GxP validation experience with key regulatory requirements.
- Expertise in relational databases, data management, and performance SQL scripting.
- Familiarity with XML, Java libraries/frameworks.
Certifications (Desirable):
- ISTQB , PMP, ISEB, SAFE, AWS, AZURE, TOSCA, QAI, CSQE
Skills
- Hands-on experience with test automation tools and frameworks.
- Proficient in Database, data validation and data quality validation.
- Experience with OpenAI LLM, APIs, and automated validation frameworks.
- Experience with build and CI/CD tools.
- Familiarity with Agile SDLC.
- Proficient with API/web services testing.
- Strong background in Security testing and cloud service architecture.
Experience
- Minimum 7 years in OO software development/architecture.
- Extensive experience in automated testing.
- Experience with orchestration engines, workflows, RPA, BPMN, and mocking frameworks.
- Experience from the pharmaceutical industry and familiar with GxP Testing and Validation frameworks.
Why Join Us?
At Genmab, you will be part of a pioneering team dedicated to developing innovative solutions that empower healthcare transformation. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth.
About You
- You are passionate about our purpose and genuinely care about our mission.
- You bring rigor and excellence to all that you do.
- You are a generous collaborator.
- You are determined to do and be your best.
- You are not afraid to grapple with the unknown and be innovative.
- You have experience working in a fast-growing, dynamic company.
- 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 for the betterment of employee work-life balance.
About Genmab
Genmab is an international biotechnology company focused on improving the lives of patients through innovative antibody therapeutics.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity and believe it is essential for our continued success.
Genmab is committed to protecting your personal data and privacy.
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires is initially to offer a fixed-term employment contract for a year.
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