En Roche puedes ser tú mismo y sentirte valorado por tus cualidades únicas. Nuestra cultura fomenta la expresión personal, el diálogo abierto y las conexiones genuinas, donde eres valorado, aceptado y respetado por lo que eres, permitiéndote prosperar tanto de manera personal como profesionalmente. Así es como buscamos prevenir, detener y curar enfermedades y asegurarnos de que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Únete a Roche, donde cada voz importa. La posición The IT Quality Specialist independently manages the end-to-end quality and analysis tasks across various capabilities and contributes to solving moderately complex business problems. You will lead the analysis of stakeholders needs, drive root cause analysis, and ensure comprehensive requirements traceability across large-scale initiatives. Acting as a trusted advisor, you will champion accountability, mentor junior team members, and drive process improvements that align delivered solutions with overarching business goals. Key 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. Experience Profile • 7-10 years of related experience in an IT business systems analyst or IT quality assurance role. • Strong 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. • BA/BS degree in life science, informatics, business, or equivalent (MA/MS or post-graduate coursework is a plus). • 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. • Strong 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. Shift: CET time zone #Hyderabad2026 Quienes somos Alcanzar un futuro más saludable es lo que nos impulsa a innovar. Juntos, más de 100.000 empleados en todo el mundo están dedicados a avanzar en la ciencia, asegurando que todos tengan acceso a la atención sanitaria hoy y para las futuras generaciones. Nuestros esfuerzos resultan en más de 26 millones de personas tratadas con nuestros medicamentos y más de 30 mil millones de pruebas realizadas con nuestros productos de Diagnósticos. Nos damos apoyo mutuamente para explorar nuevas posibilidades, fomentar la creatividad y mantener altas nuestras ambiciones, para poder ofrecer soluciones sanitarias que cambian la vida e impactan a nivel global. Construyamos juntos un futuro más saludable. Roche es una empresa que ofrece igualdad de oportunidades.