€48,000 – €64,000SeniorFull Time
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 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.
Main responsibilities:
Country Quality System Management
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.
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.
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.
Carry out the annual Country Quality Review. Monitor the related Quality Program and Action Plan follow-up.
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.
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.
Monitor MCO/country QPIs defined by Global Quality using the appropriate Global Quality computerized system.
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.
Ensure that quality clauses or quality agreements are in place in service agreements for all service providers performing GxP activities.
Ensure an appropriate quality oversight process of locally managed service providers for all GxP activities (except for CSU).
Ensure that quality risks are properly managed within the country. Provide risk management expertise to other country functions as appropriate.
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
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.
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.
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
Why choose us?
#LI-EUR
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
The salary range for this position is :€48 000,00 - €64 000Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.
