Job title: Business Quality Representative (BQR) for Computerized Systems
- Location: Val-de-Reuil (27-Eure) France
About the role
Ready to play a key role in the quality performance of a strategic vaccine production site?
Join Sanofi in Val-de-Reuil as a Business Quality Representative (BQR) to lead operational quality assurance and Computerized Systems BQR activities within the site's cross-functional departments (SQO, Sterility Assurance, Digital Services, Smart Factory, Supply Chain, Engineering and Maintenance).
You will be a preferred point of contact for internal teams and will actively contribute to regulatory compliance and continuous improvement.
As BQR for Computerized Systems (CS), you will ensure the compliance of digital tools with business processes and GxP requirements. You will work with the Business System Owners and system validation experts (CSV).
About Sanofi:
Sanofi is a biopharmaceutical company that innovates in R&D and leverages AI at scale to improve people's lives and create long-term growth. Our deep understanding of the immune system – and our innovative pipeline – allows us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we pursue the miracles of science to improve people's lives.
Main responsibilities
- Coordinate the operational quality activities of the cross-functional and support departments of the Val de Reuil site
- Act as the quality representative for the site's cross-functional services and the associated CS BQR
- Take part in managing deviations, CAPA, CCR and in quality decision-making
- Approve quality and technical documents (URS, AFU, criticality analysis, functional risk analyses…)
- Participate in on-the-floor quality routines: committees, QDCI, themed visits, problem solving
- Contribute to the preparation of site inspections and audits
A fixed salary over 12 months, plus profit-sharing and incentive scheme based on Sanofi Group results.
Because caring for our employees is also our mission: 31 days of paid leave + RTT days depending on your status, remote work up to 2 days/week, quality health insurance, public transport reimbursement up to 80%; maternity leave (18 weeks) and adoption leave (14 weeks), Savings Plan & Retirement Plans with company contributions, CSE benefits, internal and international mobility opportunities, a customizable training offer to support you throughout your career and many other benefits to discover here.
About you
Experience
- Proven experience in cross-functional management and pharmaceutical quality.
- Proven experience in computerized systems validation (CSV) will be an asset
Education
- Bac+5 (master's level), or engineering degree
Technical skills
- Good knowledge of GMP/GDP and quality processes (GxP, data integrity, FDA/EMA/GAMP 5 frameworks)
- Project skills: managing the lifecycle of systems (URS, SCA, FRA, AFU, data migration and retirement)
- Routine management skills: incident handling, periodic review management, coordination of Change Controls
- Proficiency with IT tools (Office Suite)
Interpersonal skills
- Autonomy, able to make decisions within your scope without systematic validation
- Proactivity, proposes innovative solutions and anticipates potential issues
- Versatility, comfortable working on several business areas simultaneously
- Collaboration, teamwork and natural cross-functional mindset, with excellent relationship skills
- Organization, ability to prioritize tasks and synthesize information efficiently
- Leadership, ability to positively influence teams
- Rigor, precision and method in task execution and respect for processes
Languages
- English level B1 minimum (written and spoken)
Why choose us?
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Shape the future of medicine and vaccine manufacturing and distribution through cutting-edge technologies, to ensure smooth launches and a resilient supply chain. Deliver high-level performance by leveraging digital innovation, data and artificial intelligence, with speed and at scale.
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Transform lives around the world by delivering essential treatments, everywhere and at all times.
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Work in an environment where you can grow, thrive and have real impact, a workplace that lets you give your best every day. Work with AI, robotics and next-generation automation to redefine manufacturing and distribution on a global scale.
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Take part in pioneering projects such as our Modulus plant, our smart factories and our AI-driven supply chains.
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Contribute to the launch of more than 30 new products by 2030, so patients receive their treatments faster than ever.
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Develop new skills, explore cross-functional roles and work in an environment that values learning and discovery.
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Every year, we distribute more than 4 billion medicines and vaccines, ensuring patients worldwide have access to the treatments they trust.
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Join a company that invests in its talent, in technology and in sustainable development by leading the transition to a low-carbon and digital industry.
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Enjoy exceptional benefits, including flexible working arrangements, comprehensive health coverage and well-being programs designed to help you thrive.
Always Progressing. Discovering the Extraordinary.
Join Sanofi and enter a new era of science – where your journey can be as transformative as the work we do. We invest in you so that you can go further, accelerate your thinking and achieve what has never been done before. You will help push boundaries, challenge conventions and design smarter solutions for the communities we serve. Ready to pursue the miracles of science and improve people's lives? Let's pursue progress and discover the extraordinary – together.
At Sanofi, we believe in equal opportunity, without distinction of race, colour, ancestry, religion, sex, origin, sexual orientation, age, citizenship, marital status, disability, gender identity or any other characteristic protected by law.
Pursue progress, discover extraordinary
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 :€42 400,00 - €56 533
Final 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.