Quality Engineering Architect for Life Sciences
2 weeks ago
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Senior Quality Engineering Architect, R&D Research & Drug DevelopmentAt Genmab, we strive to build innovative futures together by developing antibody products and pioneering therapies that transform the lives of patients and the future of cancer treatment and serious diseases.
About Genmab's IT & Digital Organization:
Genmab's IT & Digital team is dedicated to transforming patient care through cutting-edge technology solutions. We are seeking a skilled Quality Engineering Architect to drive the automation and enhancement of GxP workflows across our extensive portfolio of research and clinical development platforms, focusing on life sciences' critical environments.
The Role:
As a Senior Quality Engineering Architect at Genmab, you will play a key role in designing, implementing, and overseeing the validation and testing architectures for our research and clinical development platforms.
Key Responsibilities:
- Design and deliver test strategies 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 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 a master's degree.
- Proven experience in a solution automation architect role, preferably in 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, and 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 familiarity 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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