Job title
: Quality Business Partner
Location:
Barcelona, Madrid
About the job
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 integral 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.
Main responsibilities:
Country Quality System Management
Implement and maintain
Quality Policy
and country-level Quality System for all GxP activities.
Promote the legally required
quality standards
, as well as applicable local regulatory requirements and those of the Sanofi group applicable to the affiliate's key operations.
Drive
Quality culture and mindset
across the organization.
Coordinate
Quality network
across country functions.
Assure that a process for
management of GxP documents and records
is in use in all GxP areas, considering data integrity.
Country Quality documentation system
Ensure documented processes exist for all key and regulated activities. Implement Corporate Policies and SOPs at local level, ensuring local adaptation is performed when necessary to meet specific affiliate needs.
Audit & Inspection Management




Support regulatory inspections and maintain inspection readiness. Manage local audit strategy for GxP activities. Monitor and follow up on audit findings. Coordinate with Quality Audit Intelligence teams.
Training and Personnel Qualification
Manage and organize quality-related information sharing and training sessions at country level. Ensure that there are system, process and procedure in use for the personnel qualification (e.g., CV, job description, 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.
Deviation and CAPA management
:
Ensure that a process to timely manage deviations and CAPAs related to all GxP activities across the country is in use in a consistent manner.
Change Control management
:
Ensure that a process is in use across the country to manage proposed changes that may impact GxP processes or operations, implementing risk assessment and action plans when necessary.
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. Implement and manage S&TC; with manufacturing sites, maintaining them valid and current in accordance with applicable regulations.
Other service agreements
:
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. Provide risk management expertise to other country functions as appropriate.
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
Product complaints
Ensure proper management product complaints received from the markets, including suspicious product cases, in coordination with the central PTC organization. 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 global and local processes, including mock recalls. Provide support on

📌 Quality Business Partner (Laza)
🏢 Sanofi
📍 Laza