IT Quality Specialist (RDT Biometrics & Clinical Evidence Madrid)

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 Position

Are you a highly skilled Business Systems Analyst or IT Quality professional looking for a creative challenging environment We are seeking an individual to join our team in South San Francisco to help deliver cost-effective sustainable and compliant business solutions.

Your Responsibilities

• Collaborate with cross-functional teams including Product Managers Architects Engineers and UX Designers to define scope solutions constraints and project risks.

• Manage compliance documentation processes and systems characterizing business solutions for compliance with internal and external regulations.

• Be accountable for the creation and maintenance of:

  • System Risk Assessments and Data Classification Reports.

  • User Requirements and Functional/Technical Specifications.

  • Validation Plans Reports and Registries.

  • Requirements Traceability Matrices Test Plans and Test Reports.

  • Data/Process flow diagrams and training documentation.

• Configure system settings and provide consultation to customers regarding solution enhancements and new implementations.

• Facilitate UAT planning and execution.

• Serve as a trusted partner for Global Privacy IT Security and Business Quality teams maintaining expert-level knowledge of governance standards (e.g. GDPR CCPA HIPAA 21 CFR Part 11 ISO 13485).

• Drive the resolution of business or systems issues throughout the project lifecycle.

• Enhance the creation and maintenance of compliance documentation (e.g. System Risk Assessments Validation Plans Requirements Traceability Matrices) by leveraging AI-driven automation to reduce manual effort while maintaining compliance rigor.

• Implement AI-assisted quality control tools to automate data validation anomaly detection and cross-platform consistency checks ensuring sustained data integrity and adherence to GxP/CSV standards at scale.

• Utilize AI-powered analytical tools to monitor platform performance proactively identify process bottlenecks and generate audit-ready compliance metrics.

• Guide the strategic deployment of AI agents within the IT Quality landscape ensuring that AI-assisted workflows remain compliant by design and effectively support business requirements.

Who You Are

• You hold a BA/BS degree in life science informatics business or equivalent (MA/MS or post-graduate coursework is a plus)

• You built 6 to 8 years of related experience in an IT business systems analyst or IT quality assurance role

• You built advanced domain knowledge of the pharmaceutical/biotech industry manufacturing/quality assurance processes and computer systems validation (CSV).

• Proven understanding of application development methodologies (Agile and Waterfall) including functional requirements process modeling and large-scale system implementations.

• Excellent written and verbal communication presentation and facilitation skills

• Demonstrated ability to build relationships focus on the customer and solve complex problems in fast-paced environments

• Advanced capability to independently apply tools principles concepts and techniques related to requirements data usability and process analysis

• Ability to champion accountability by example drive process improvement initiatives and mentor junior team members

#RDT2026

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1