Quality Processes Digitalization Business Expert (QMS)

• Job title: Quality Processes Digitalization Business Expert (QMS)

• Location: Budapest, Hungary

• Job type: Permanent, full-time

• Hybrid working (60% office, 40% home)

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

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment

• Work from an "Office of the Year 2023" award winner with flexible home office policy

• 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

• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks

• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

PursueProgress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

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