Quality & Regulatory Analyst – South America Network

About the role

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. You will manage, simplify, and automate Quality Management System tools across the network, warehouses, and distributors.

Key responsibilities

• Oversee daily Quality Management System tools (change control, risk analysis, non‑conformities, complaints, deviations) and drive simplification and automation.
• Make compliant product release and reject decisions, ensure batch record traceability, manage returns and monitor blocked, expired or quarantined stock.
• Design and execute the Validation Master Plan, manage warehouse instrument calibration, temperature monitoring and deliver GxP training.
• Draft, review and execute Quality Agreements with suppliers and distributors, ensuring third‑party compliance.
• Collaborate on the Annual Audit Plan, support health‑authority inspections and maintain ISO 9001/13485 documentation.
• Participate in commercial and business squads as a quality partner to support local and regional objectives.

Required profile

• 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, GxP guidelines and regional Health Authority regulatory frameworks.
• Hands‑on experience managing QMS tools (deviations, CAPAs, change control) and executing validation/calibration plans.
• Fluency in Spanish and professional working proficiency in English; currently based in Uruguay with valid work authorization.

Required skills

• ISO 9001
• ISO 13485
• GxP compliance
• QMS tools (deviation management, CAPA, change control)
• Validation planning and calibration