Quality Business Partner The Country Quality Team, led by the Country Quality Head, ensures quality standards across all country processes and activities, including management of product quality, complaints, regulatory compliance, and support other departments in quality-related matters. The team maintains the local quality management system, balancing global Sanofi standards with local regulations while supporting various business functions.

About Sanofi: We're an R&D-driven;, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Country Quality System Management Quality

Policy and country-level Quality System for all GxP activities. quality standards , as well as applicable local regulatory requirements and those of the Sanofi group applicable to the affiliate's key operations. Quality culture and mindset Quality network is in use in all GxP areas, considering data integrity.

Country

Quality documentation system Implement Corporate Policies and SOPs at local level, ensuring local adaptation is performed when necessary to meet specific affiliate needs. Manage local audit strategy for GxP activities. Coordinate with Quality Audit Intelligence teams.

Training and Personnel Qualification Manage and organize quality-related information sharing and training sessions at country level. CV, , training curricula and records)



and the management of GxP trainings across the country by each GxP function. Develop and implement continuous training programs for GxP functions, as an active member of LISA working group.

Country Quality Review: Carry out the annual Country Quality Review. Monitor the related Quality Program and Action Plan follow-up.

Country Quality Performance

Indicators (QPI) : Monitor MCO/country QPIs defined by Global Quality using the appropriate Global Quality computerized system.

Country Quality Agreements : Implement and manage technical and quality agreements with subcontracted companies whose activities have GxP relevance. Ensure that quality clauses or quality agreements are in place in service agreements for all service providers performing GxP activities. Quality oversight of locally managed GxP service providers : Ensure an appropriate quality oversight process of locally managed service providers for all GxP activities (except for CSU).

Quality Risk Management

Ensure that quality risks are properly managed within the country.

Computerized

Systems (CS) and digital properties Maintain an up-to-date local inventory of GxP CS (exception for CSU) and digital properties and check if the locally owned GxP CS are validated as per Sanofi requirements.



Analyzing all digital proposals from the affiliate and ensuring GxP compliance for all digital initiatives.

Product Quality

Conduct product complaints' trend analysis and signal detection, as per Sanofi requirements and local regulations. Product-related quality events Escalate quality events occurring at the country level and manage subsequent quality alerts and product alerts. Manage product recalls as per integral and local processes, including mock recalls.

Provide support on Quality matters to the appropriate functions at country level and according to the defined responsibilities regarding Regulatory Authorities. Ensure quality management of marketed products and associated services, including launch readiness and distribution of free medical samples and medical devices, when applicable. Evaluate PQRs for products where Spanish affiliate is MAH or local representative, issuing quality conclusions.

Develop and maintain annual local PQR review tracker aligned with Global PQR plan. Assure that any local GMP and/or GDP activities when under CQH responsibility (repackaging, storage, distribution, quarantine, batch blocking, etc.) are performed in accordance with applicable local GMP and GDP regulations. Ensure that foreign medication products are reviewed and distributed in accordance with Group directives, GMP, GDP guidelines, and local legal requirements.

Demonstrated proficiency in pharmaceutical industry (Quality preferred) Regulatory Compliance Quality Management System Improvement fluent spanish and professional english Work with AI, robotics, and next-gen automation to redefine global manufacturing and supply. ALL IN video

📌 Quality Business Partner (Laza)
🏢 Sanofi
📍 Laza