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Madrid, Comunidad de Madrid, España
Hybrid
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
In Roche, compliance is our license to operate so we are committed to the quality of the product we deliver. Everyone's contribution will have an impact on patients, so in everything we do, we think about patient safety.
You will be responsible for the evaluation, design, development and creation/review/approval of qualification deliverables such as qualification plans, protocols and reports, for qualified platforms in the Enterprise Cloud product area.
In liaison with IT Quality and the Enterprise Cloud product teams you will help to ensure platforms are implemented and maintained in accordance with the appropriate regulatory agency requirements, our company standards, and current industry practices. You will continuously assess/review internal qualification processes and procedures, making recommendations for improvements.
Your Responsibilities
Ensure that the qualified state of platforms is maintained, keeping them audit and inspection ready. Ensure that IT controls (e.g. Configuration/Change Management, Security/Access Management, Periodic Reviews, Audit Trail, Backup and Restore, Incident management, etc.) are in place using appropriate tools and in alignment with our company standards, to support the implementation and maintenance of the platform.
Design, build, and maintain automated compliance checks, continuous testing, and reporting directly within the CI/CD pipeline (e.g., automated execution of qualification/validation test suites, static code analysis for security and compliance, automated release documentation generation). Your goal is to turn manual quality gates into automated, code-level checks so engineering teams can move fast without compromising regulatory standards.
Act as the technical bridge between DevOps/Engineering and the IT Quality Assurance (ITQA) and Validation teams. Serve as an expert advisor on how to translate complex pharma regulations into concrete technical implementation patterns, pipeline guardrails, and actionable automated policies.
Develop custom scripts, hooks, CLI tools, or infrastructure-as-code modules that dynamically capture execution evidence, maintain immutable audit trails, and automatically flag compliance deviations or non-conformances directly within active developer workflows (PRs/commit checks) before code hits production.
Partner with the team leads to modernizing traditional validation paradigms toward continuous testing and "Compliance as Code." Provide ongoing coaching to software and infrastructure engineers on best practices for traceable, compliant code authoring while reducing friction and lead time for high-regulated software deliverables.
Develop/review/approve qualification documentation, such as qualification plans and reports according to Roche CSV SOPs. Review qualification activities, ensuring that the platforms are compliant throughout their lifecycle.
Deliver expert guidance on IT qualification and compliance to System Owners, Process Owners, and SMEs. Support deviation investigations to pinpoint root causes, execute effective corrective and preventive actions, and represent the IT compliance team throughout internal and external audits.
Who You Are
Bachelor's or Master’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
Demonstrated ability to research technical topics, learn new tools quickly, and a strong desire to develop expertise in Cloud and DevOps practices.
Ability to work effectively within a team, actively participating in discussions and code reviews.
1+ years of hands-on experience in quality engineering (including validation and software testing) or a comparable discipline in the pharmaceutical, biotechnology, or regulated healthcare technology industry.
Regulatory Awareness: Understanding and experience working with regulations/guidance (e.g. FDA 21 CFR Part 11, EU Annex 11, GxP practices, etc.)
Familiarity with incident response, including supporting the adoption of ITSM processes and conducting blameless postmortems.
Experience supporting regulatory inspections and audits is a plus.
Basic understanding of core public cloud services.
Hands-on experience building Cloud applications via Terraform or CDK.
Familiarity with Gitlab/Github, SDLC practices and CI/CD.
Hands-on experience using scripting languages such as Python or Bash and testing frameworks like Pytest.
Familiarity with Agile methodologies (SAFe), principles, processes, and tools.
Openness to using AI assistants to support learning, code generation and debugging.
Proactive approach to troubleshooting issues and finding potential solutions.
Effective verbal and written communication skills. Proficiency in English is a must.
Experience working collaboratively in cross-functional, diverse and agile teams.
Adaptability, problem-solving and openness to feedback.
Intellectual curiosity and integrity and strong passion for innovation.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.