Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.
Die 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
Wer wir sind
Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.
Gemeinsam können wir eine gesündere Zukunft gestalten.
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.
