LIMS Senior Expert

Position title: LIMS Senior Expert

• Location: Budapest – Sanofi Business Services, Váci Greens

• Hybrid working

Our Team:

Manufacturing & Supply (M&S) services is a transforming strategic area in Sanofi. The Quality Digital Solutions team is responsible to ensure the successful & compliant transformation of design and implementation 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.

Our Position

The LIMS Senior Expert is responsible for leading the implementation, management, and optimization of Laboratory Information Management Systems (LIMS) across Sanofi sites. This role ensures standardized processes, effective data management, data integrity, development and value realization through LIMS deployment while maintaining compliance with GxP regulations.

Main responsibilities:

LIMS Deployment Management

Drive effective management of LIMS deployment including scoping, budget monitoring, and capacity planning.

Ensure consistent implementation across sites with adherence to data management rules.

Monitor progress, track deliverables, and provide regular reporting to stakeholders.

Project & Resource Management

Manage project resources and allocation, adjusting based on business or technical needs.

Coordinate with Digital teams, site project teams, and Program Lead.

Lead risk management and implement appropriate mitigation strategies.

Lifecycle Management & Compliance

Ensure compliance throughout solution lifecycle (change control, risk assessment, incident management).

Support user community through training and community animation.

Handle changes at core solution level in liaison with Global System Owner and Process Owners.

Quality Process Standardization

Lead standardization of quality processes and ways of working.

Ensure consistent master data implementation across sites.

Coordinate usage consistency across organizations/GBUs aligned with process design.

Value Realization & Performance

Drive value realization to achieve paperless targets, business value, and cycle time reduction.

Measure solution implementation impact through KPIs defined with Performance team.

Provide technical support to sites for issue management and troubleshooting.

About you

Experience:

10+ years of experience in pharmaceutical industrial Quality organization

Hands-on experience in QC area and QC processes execution

Robust knowledge of LIMS solutions

Experience on project management (waterfall & agile) or people management preferred

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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

Knowledge & experience of computerized systems, validation and in Data Integrity

Soft skills:

Quick decision making and be able to drive the change

Good communication and motivation of colleagues

Results-focused, problem-solving and proactive

Action-oriented, results-driven mindset with a focus on customer outcomes

Education: Technical/scientific education, data management

Languages