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 global Sanofi standards with local regulations while supporting various business functions.
Job title: Quality Business Partner
Location: Barcelona, Madrid
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.
* 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 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.
GMP and GDP Activities
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. Ensure customer GDP qualification. Manage and make decisions regarding temperature excursion during storage or transport.
About You
* Demonstrated proficiency in pharmaceutical industry (Quality preferred)
* Education: University Degree in Life Sciences
* Soft Skills: Teamwork Influencing Others People Leadership Results Oriented Strategic Thinking Collaborative Communications
* Technical Skills: Preventive Action Regulatory Compliance Operational Excellence Corrective Action Management Risk Management Change Management Quality Management System Improvement Inspection Readiness Problem Solving
* Languages: fluent spanish and professional english
Benefits
* Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
* Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride.
* Work with AI, robotics, and next-gen automation to redefine global manufacturing and supply.
* Be part of world-first initiatives like our Modulus factory, smart factories, and AI-driven supply chain solutions.
* Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever.
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