Supply Chain Compliance Expert

• Hybrid working
• Location: Budapest

About the job

Our Company

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions.

As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world.

Within Sanofi the Global Business Operations is responsible for delivering and supporting Global Manufacturing & Supply (M&S) Services by acting as a central organization.

Our Team

Transformation of Manufacturing & Supply (M&S) services is a strategic concept in Sanofi. The Quality Programs team is responsible to ensure the successful & compliant design and implementation of Quality Digital solutions supporting this strategic transformation of Quality operations, towards simplified, standardized & digitalized processes. The scope includes all projects within the quality global function: Quality Management Systems, Quality control, Supply Chain & manufacturing as well as Analytics related projects.

This includes the ownership of the solution and relative data for the Quality Function: structure and maintenance of the global quality data referential (QA/QC) and to advise on it’s appropriate and consistent usage across digital projects and processes. It covers application of KPIs & artificial intelligence for Quality.

Main responsibilities

As a Supply Chain Compliance Expert You contribute to the execution of projects in the frame of transformation & digitalization, including accountability for appropriate & compliant design of simplified and standardized processes defined by relevant Business Process Owners, manage planning, quality of the delivery, compliance, and excellence in execution at shopfloor level (site, affiliate, entity).This also includes compliance of the digital solution upon design, deployment and all along life cycle management.

Under the supervision of the Global Solution Lead, and the umbrella of the Program Lead, contribute to the delivery (build, deploy and support to routine usage) of M&S Supply Chain capabilities (related to serialization or secured Batch release & shipment to Market or eBatch release protocol towards heath authorities or Batch traceability & genealogy or digitalized forms at shopfloor manufacturing & warehousing).

Supply chain compliance

• Contribute to project execution & successful delivery of compliant global digital quality solutions in alignment with the defined strategy and process designed (adherence to prescribed process, user stories scripting, risk assessment, UAT scripting & execution, defect management, training material delivery, user adoption & support along life of the system)
• Contribute to the implementation of a clear and consistent approach to manage one of the following projects: serialisation, end to end traceability, batch release and market allocation, trend analysis and system compliance
• Ensure close collaboration with digital teams & partner solutions / teams as needed

Support deployment & process transformation

• Support the transformation of processes and ways of working associated with standardisation, centralisation and harmonisation
• Contribute to user adoption, and support end users in daily operations (trouble shooting, detection of falsification…)
• Coordinate and ensure consistency of usage (across organizations/GBUs) in adequation with real needs and process design
• Ensure Life cycle management & compliance along time (deviation management, incidents solving, change control, etc..) in liaison with BPOs, Global Solution business owner and digital teams
• Support measurement of the impact of the solution implementation through relevant KPIs defined with Performance team and the relevant BPOs

About you

Experience

• Supply Chain related experience and knowledge in pharmaceutical industry for shopfloor processes (such as serialization, batch release & secured shipments, traceability & flows, maintenance & calibration, cleaning …)
• Significant experience in digital projects preferably in agile mode in pharmaceutical Manufacturing & Supply and/or Quality areas

Technical skills

• Rigorous in an agile working environment
• Ability to communicate, deliver & report
• Action & result oriented
• Team player
• Pronounced appetite for digitalisation & data
• Knowledge & experience of computerized systems GxP requirements & validation and in Data Integrity

Education

• Technical/scientific education

Languages

• Good level of Professional English (mandatory)

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

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