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 technology industry.
Technical Expertise
Regulatory Awareness: Understanding and experience working with regulations/guidance (e.g. 21 CFR Part 11, EU Annex 11, GxP practices, ALCOA+, etc.)
Familiarity with incident and deviation response
Experience in supporting the adoption of ITSM processes (Change Management, Deviation Management, etc).
Experience supporting regulatory inspections and audits is a plus.
Basic understanding of core public cloud services is a plus
Hands-on experience building Cloud applications via Terraform or CDK.
Familiarity with Gitlab/Github, SDLC practices and CI/CD is a plus.
Hands-on experience using scripting languages such as Python or Bash and testing frameworks like Pytest.
Experience in using AI assistants ,
Experience in code generation and debugging.
Proactive approach to troubleshooting issues and finding potential solutions.
Required Skills
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.
Who we are
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.
