IT Quality Specialist - Pharma R&D

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

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 risksManage compliance documentation processes and systems, characterizing business solutions for compliance with internal and external regulationsBe accountable for the creation and maintenance of:System Risk Assessments and Data Classification ReportsUser Requirements and Functional/Technical SpecificationsValidation Plans, Reports, and RegistriesRequirements Traceability Matrices, Test Plans, and Test ReportsData/Process flow diagrams and training documentationConfigure system settings and provide consultation to customers regarding solution enhancements and new implementationsFacilitate UAT planning and executionServe 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 lifecycleEnhance 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 rigorImplement 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 scaleUtilize AI-powered analytical tools to monitor platform performance, proactively identify process bottlenecks, and generate audit-ready compliance metricsGuide 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 roleStrong 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 implementationsBA/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 skillsDemonstrated ability to build relationships, focus on the customer, and solve complex problems in fast-paced environmentsStrong capability to independently apply tools, principles, concepts, and techniques related to requirements, data, usability, and process analysisAbility to champion accountability by example, drive process improvement initiatives, and mentor junior team members.

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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.