Business Quality Representative for Manufacturing Digital Solutions

• Job title: Business Quality Representative for M&S Digital Solutions

• 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 Business Quality Representative, you will play a vital role in supporting quality related activities for digital solutions used in Manufacturing & Supply chain processes. Under guidance from senior quality professionals, this role assists in ensuring that computerized systems comply with GxP regulations (GMP, GDP) and maintain compliance & data integrity throughout their lifecycle. The position focuses on supporting validation activities, reviewing documentation, addressing issues upon solution usage & associated risks to compliance, to product, patient or data, collaborating with cross-functional teams to maintain quality standards for digital solutions in a pharmaceutical manufacturing environment.

Main responsibilities:

Design/Build Phase

• Review User Requirements Specifications (URS) and user stories to verify inclusion of basic GxP controls such as user access management, audit trails, and data integrity requirements.

• Assist in documenting system criticality assessments (SCA) based on the types of GxP records managed by the system.

• Support Functional Risk Assessments (FRA) by identifying potential risks related to system functions and data integrity controls.

• Verify that data integrity principles (ALCOA+) are documented in business requirements and system specifications.

• Assist in reviewing systems for operational approval by confirming completion of qualification activities, testing protocols, and required Standard Operating Procedures (SOPs).

Deployment Phase

• Review deployment documentation to confirm data integrity readiness and basic regulatory compliance requirements.

• Provide quality support during system deployment activities to ensure smooth transition to operational use.

Lifecycle Management Phase

• Participate in risk evaluation activities for identified risks during system operation.

• Support the implementation of risk controls and Corrective and Preventive Actions (CAPAs). Ensure adequate communication across network of measures to be taken.

• Maintain regular communication with:

  • Business Process Owners in manufacturing and supply chain to ensure alignment between quality requirements and operational needs.

  • Digital solution owners and Business system owners to ensure adequate & exhaustive compliance integration by design in digital capabilities, issue resolution, GxP deviations handling & CAPA definition & execution.

  • Global quality functions.

• Assist with ongoing compliance assessments and periodic review activities.

• Support compliant system retirement activities, including GxP records retention and data migration activities.

About you

Experience:

• 5+ years in pharmaceutical quality assurance or GxP computerized systems.

• Exposure to pharmaceutical manufacturing or supply chain operations is a plus.

Technical Skills:

• Knowledge of data integrity principles and regulatory requirements (FDA 21 CFR Part 11, EU Annex 11, ALCOA+).

• Familiarity with computer system validation (CSV) activities for systems such as ERP, MES, or data management platforms.

• Working knowledge of GxP regulations applicable to computerized systems.

• Basic understanding of electronic records and electronic signatures requirements.

• Understanding of quality risk management principles.

• Ability to review business process documentation (URS, FRA, SCA, validation protocols).

• Basic understanding of system data flows and data integrity controls.

Soft skills: 

• Effective communication skills (written and verbal) with various stakeholders

• Good collaboration skills and ability to work in cross-functional teams

• Willingness to learn and develop expertise in quality systems

• Proactive approach to problem-solving

Education:

• Degree in Life Sciences, Pharmacy, Engineering, Computer Science, or related field

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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