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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.
The PositionA healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
Pharma Technical (PT) Digital and Operational Excellence (PTE) is establishing a Validation & Inspection Readiness Team. You will play a vital role in ensuring the quality, compliance, and reliability of data products and digital solutions that drive real-world impact on processes and products within Pharma Technical Operations (PT). You'll work in a multi-disciplinary environment, collaborating closely with data engineers, subject matter experts, and other data product and digital solution teams.
This crucial role focuses on the evaluation, design, development, and approval of testing documentation—including plans, testing evidence and reports—for computerized systems across different domains and product lines. Beyond direct contributions, you will help develop and implement streamlined testing standards to guide data product and digital solution teams across PT. This requires an individual who is highly motivated, collaborative, adaptive, and dedicated to delivering value while strictly maintaining GxP compliance and regulatory requirements.
The Opportunity:
Determine Testing Strategy: Define testing approaches and identify deliverables needed or impacted by GxP data product and digital solution use cases.
Develop & Approve Documentation: Be responsible for the evaluation, design, review and approval of testing plans/reports and testing evidence (and other testing related deliverables), creation of test cases based on requirements, execution of test cases to perform end-to-end testing of the data products and digital solutions to ensure functional requirements are met and fit for purpose.
Compliance and Release: Ensure the testing deliverables for the data products and digital solutions adhere to Roche SOPs, CSV frameworks and regulatory guidance.
Data Quality & Data Integrity: Adhere to ALCOA++ and FAIR principles to ensure the highest standards of data quality and data integrity.
Test Automation: Lead automation efforts by designing and implementing automated testing framework, and execute automated test scenarios.
Set Best Practices: Champion delivery of data products and digital solutions, contribute to best practices, and coach data product and digital solution teams on testing approaches streamlined for data systems and processes, with a risk-based focus aligned with testing rigor.
Ensure Sustained Compliance: Support data product and digital solution maintenance and enhancement activities, ensuring the testing deliverables support the validated state, and that issues, defects and any departures from expected acceptance criteria are documented and addressed as per Roche SOPs and processes, to support a state of audit and inspection readiness.
Support Investigations: Support deviation investigations to identify root causes and define corrective and/or preventative actions.
Audit Expertise: Support system audit/inspection preparation and execution as a testing subject matter expert.
Periodic Review: Support data product and digital solution periodic reviews according to internal procedure.
Who you are
Experience & Education: University degree with 3+ years in IT & Software Validation (CSV/CSA, GAMP).
Design & Build: Proven experience in building/managing data pipelines, test automation and developing testing for data products and digital solutions.
Tools: Proficient with the use of test management and CI/CD tools.
Regulatory Knowledge: Sound knowledge of regulations/guidance (i.e., CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, EU AI Act, GxP practices).
Technical Understanding: Good understanding of system and data risk assessment, and general understanding of Agile Methodology Framework (i.e., SAFe, Scrum)—previous experience is an advantage.
Collaboration & Communication: Excellent verbal and written communication skills with the ability to clearly communicate complex solutions to audiences of varying technical experience and seniority.
Adaptability: Able to work on co-located or remote cross-functional teams to achieve milestones and goals, with an ability to quickly adapt to an ever-changing environment.
**Relocation benefits not available for this position**
Who we areA 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.
