Quality & Regulatory Analyst

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 As a Q&R Analyst for the South America Network (SAN), based in Uruguay , you will ensure Roche’s license to operate by overseeing compliance with local Health Authorities, corporate standards, and ISO 9001 & 13485 requirements. Reporting within the Marketing & Sales division, you will manage, simplify, and automate Quality Management System (QMS) tools across the network, warehouses, and distributors. In this role, you will lead validation plans, handle product release decisions, conduct GxP training, manage quality agreements, and support internal and external audits to safeguard business continuity and product quality. The Opportunity QMS Management & Innovation: Oversee daily Quality Management System tools (change control, risk analysis, non-conformities, complaints, and deviations), driving process simplification, automation, and company-wide adherence. Product Release & Inventory Control: Make compliant product release/reject decisions, ensure complete batch record traceability, manage customer returns, and track blocked, expired, or quarantined stock. Validation & GxP Compliance: Design and execute the Validation Master Plan, annual warehouse instrument calibration, temperature monitoring plans, and GxP training for relevant internal teams. Distributor & Supplier Oversight: Draft, review, and execute Quality Agreements with suppliers and distributors, ensuring third-party compliance and training on QMS requirements. Audits & Regulatory Alignment: Collaborate on the Annual Audit Plan, participate in health authority inspections, maintain up-to-date documentation according to ISO 9001/13485 standards, and advise business units on evolving regulations. Agile Collaboration: Participate in commercial and business squads as a quality partner to support local and regional business objectives. Who You Are Degree in Pharmacy, Biochemistry, Chemistry, Industrial Engineering, or a related scientific/technical discipline. Proven experience in Quality Assurance, Quality Systems, or Regulatory Compliance within the pharmaceutical, diagnostic, or medical device industry. Strong knowledge of ISO 9001 & ISO 13485 standards, GxP guidelines, and Health Authority regulatory frameworks across the region. Hands-on experience managing QMS tools (deviations, CAPAs, change control) and executing validation/calibration plans. Strong analytical, communication, and cross-functional collaboration skills, with the ability to influence teams and work in agile squad environments. Fluency in Spanish and professional working proficiency in English to interact with regional and corporate network teams. Must be currently based in Uruguay or hold valid work authorization. No relocation benefits are offered for this position. 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.