About the job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

The Manufacturing & Supply (M&S) Quality Digital Solutions team drives the transformation of Quality operations at Sanofi. Our mission is to simplify, standardize, and digitalize processes across Quality Management Systems (QMS), Quality Control, Supply Chain, Manufacturing, and Analytics-related projects.

We oversee Quality data management, ensuring its consistent and efficient use across projects, and we apply KPIs and artificial intelligence to enhance Quality operations.

As a Quality Processes Digitalization Business Expert, you will play a vital role in driving digital transformation of Quality operations by designing, implementing, and maintaining compliant digital solutions that simplify and standardize quality processes across global manufacturing and supply operations.

Main responsibilities:

Project Management & Delivery

Lead project activities for quality digital solutions under Program Lead supervision
Collaborate with Digital teams, end users, and country Quality/Supply Chain teams
Define user requirements and technical specifications for digital solutions
Develop and execute validation strategies, testing protocols, and compliance reports
Manage system deployment0 activities and user adoption initiatives

Compliance & Risk Management

Ensure GxP compliance throughout system design, deployment, and lifecycle management
Identify and mitigate compliance risks associated with digital system design and usage
Oversee change control processes in collaboration with stakeholders
Handle deviations and implement corrective/preventive actions (CAPA)
Maintain regulatory compliance from implementation through decommissioning
Connect market-level product complaint intake systems to central complaint management platforms
Provide operational support and troubleshooting to end users

Data Management & Analytics

Implement temperature monitoring and excursion management solutions for product storage/transport
Maintain global quality data referential (QA/QC) structure and integrity
Advise on appropriate and consistent data usage across digital projects
Support implementation of Quality KPIs and artificial intelligence applications
Ensure data quality and accessibility for decision-making processes
Ensure consistent digital system usage across the global network
Monitor system performance and drive continuous improvement initiatives

About you

Experience:

5+ years in pharmaceutical Quality operations with digital solution experience
Expertise in GxP digital projects and regulated environments
Strong knowledge of computer system validation in GxP contexts

Technical Skills:

Action-oriented, results-driven mindset with a focus on patient outcomes
Proven experience in digital solution design, validation, and implementation

Soft skills: 

Results-driven and action-oriented approach
Strong collaboration and stakeholder management skills
Change management and adaptability capabilities
Customer and patient-focused mindset

Education:

Background in technical/scientific fields or data management

Languages:

Professional English proficiency is mandatory