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The Position

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 Digital Quality and the Enterprise Cloud product teams you will help to ensure platforms are implemented and maintained qualified 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, Deviation Management, etc.) are in place using appropriate tools and in alignment with our company standards,



to ensure the platform meets regulatory compliance standards.
- 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, etc.). Your goal is to turn manual quality and qualification gates into automated, code-level checks so engineering teams can move fast without compromising regulatory and company standards.
- Act as the technical bridge between DevOps/Engineering and the Digital Quality Assurance (Digital QA). Serve as an expert advisor on how to translate complex regulation requirements 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 qualification toward "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.
- Define qualification strategies and 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.
- Drive the execution of validation and/or qualification activities in alignment with established best practices, governance and frameworks for CSV/CSA by Quality and regulatory bodies to support audit and inspection readiness.
- Deliver expert guidance on IT qualification and compliance to System Owners, Process Owners, and SMEs to support organizational understanding of qualification best practices, governance framework and compliance standards. Support deviation investigations to pinpoint root causes, execute effective corrective and preventive actions, and represent the IT compliance team throughout internal and external audits.
- Define and review compliant account migration plans, ensuring alignment with organizational governance and external regulatory frameworks

Who You Are

Educational background

- 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.

Experience

- 1+ years of hands-on experience in quality (including validation and qualification) in the pharmaceutical, biotechnology, or regulated healthcare techno

📌 Cloud DevOps (España)
🏢 Roche
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