Quality Business Solutions Expert (Manufacturing & Supply)

Our Position

The Serialization & global traceability Expert support is in charge of supporting the Global Solution owner in leading the implementation, routine management, and optimization of serialization solution supporting prevention & detection of falsified medicines on the markets, and the Global Traceability solution. This role ensures standardized processes, effective data management, data integrity and value realization through solution design & implementation while maintaining compliance with applicable regulations related to serialization of medicines & GxP regulations.

Context: Serialization & Global Traceability

Responsibility covers serialization tasks intended to prevent & detect potential falsified medicines on the various Markets. The role aims identifying products manufactured by Sanofi in a unique way to guarantee the origine of our medicines and secure usage for patients. Global traceability is a digital solution that provides end to end traceability (upstream & downstream) of products: from raw material to finished products.

Solution design & test:

• Support Global Business Solution Owner Deliver User stories / functional specifications in liaison with Digital teams supporting the defined process
• Tests & validation: ensure compliance of the solution in defining adequate risk based validation approach
• Build demonstration of the validation status of the solution
• Deliver training material, SOPs / Job aids to end users

Solution implementation:

• Support Global Business Solution Owner in driving effective deployment of the solution
• Ensure consistent usage across organizations and adherence to data management rules
• Ensure adequate support to users

Lifecycle Management & Compliance:

• Ensure compliance throughout solution lifecycle
• Support user community through training and community animation
• Handle changes, trouble shooting and incidents escalation with digital teams and business partners at core solution level in liaison with Global System Owner and Process Owner

Process Standardization:

• Contribute to standardization of processes and ways of working
• Coordinate usage consistency across organizations/GBUs aligned with process design and SOPs/job aids

About you

Experience:

• 5+ years of experience in pharmaceutical industry
• Hands-on experience in serialization
• Experience in digital / computerized systems in project mode

Technical skills:

• Proven experience in GxP regulated environments
• Solid knowledge of computer system requirements & validation
• Experience implementing digital solutions in GxP contexts
• Ability to communicate, deliver & report
• Action & result oriented
• Pronounced appetite for digitalisation & data
• Trouble shooting & anticipation

Soft skills:

• Good communication
• Results-focused, problem-solving and proactive
• Action-oriented, results-driven mindset with a focus on customer outcomes

Education: Technical/scientific education, engineering (life sciences)

Languages: Good level of Professional English

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• Play an instrumental part in creating best practice within our Procurement Team for Indirects having a great opportunity to be part of a diverse team while you will gain Manufacturing and Supply chain procurement knowledge as well

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!

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