Quality System Manager

Budapest

About the job

In the EM CHC EULA (External Manufacturing Consumer Healthcare Europe & Latam) division, we are dedicated to achieving excellence under the guidance of a diverse leadership team. The role in question supports the team leader, quality, and regulatory personnel to ensure the compliant management of all Contract Manufacturing Organizations (CMOs) and associated products within EM CHC EULA, adhering to current Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), pertinent regulatory requirements, and Sanofi’s internal standards.

The incumbent acts as the process owner for designated processes and serves as the Key User for specified computerized systems.

Key internal and external relationships include: CHC External Manufacturing Quality Assurance, CHC External Manufacturing Quality System, Global Quality External Manufacturing, Global Manufacturing & Supply, Supply Chain Managers, Quality System Excellence, Contract Manufacturing Organizations, and Distribution Centers.

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world

Main responsibilities:

Designs, implements and develops the Quality System Processes’ under it’s responsibility and ensures its compliance with applicable regulations and applicable Global Quality documents.

Deviations and Change Control:

• Administer Connect QMS system and Support

• Carry out regular analyses (review of quality event trends, etc.)

• Ensure the management of Changes Control and deviations on the perimeter of Quality Systems (creation, evaluation, definition of action plan and implementation) and maintenance of the processes (improvement, update..)

Third party audits :

• Build the annual third party audit schedule and follow up its realization

• Conduct periodic reviews, ensure quality audits of third parties in its area of expertise and maintenance of the process and related documents (improvement, updates..)

Risk management:

• Prepare and coordinate quarterly risk review

• Ensure the management of risks on the perimeter of the Quality systems (creation, evaluation, definition of action plan and implementation) and maintenance of the process and related documents (improvement, updates..)

Annual quality review:

• Prepare and participate in the annual quality review and monitor action plans

Training:

• Design and follow up the EM CHC Europe LMS quality training system and process

GQA audits :

• Participate in the deployment of the inspection readiness tool

• Prepare and participate in audits

Documentation system:

• Ensure the deployment and management of the documentation system

• Monitor the update of the global documents applicable to the entity and ensure consistency with the local document system (implementation and monitoring of the "global quality documentation assessment " process + “common” process)

KPI:

• Coordinate the collection of quality KPIs and participate in the report in the appropriate tools + during periodic reviews

Self Inspection:

• Build and validate the annual planning and monitor its implementation

• Ensure maintenance of the process and related documents (improvement, updates..)

Computerized systems :

• Design and maintain the inventory of computerized systems with their respective GxP criticality.

• Carry out periodic access reviews on GxP systems

• Ensure maintenance of the process and related documents (improvement, updates..)

Transportation Management:

• Design and monitor the implementation of the transportation management system in accordance with applicable Global Quality documents

• Guarantee the qualification of the carriers used in the entity

About you

• You have honed your expertise over several years in the pharmaceutical industry, with a preference for quality roles such as quality control, assurance, and systems management.

• You are well-versed in pharmaceutical regulations and GMP, and you possess a solid understanding of computerized systems, including the MS Office suite. Your ability to work effectively in diverse teams across multiple locations is matched by your excellent communication skills and your analytical, structured approach to problem-solving.

• You are proactive, collaborative, and carry a strong sense of responsibility, self-confidence, and rigor.

• Your autonomy, reactivity, and ability to anticipate needs demonstrate your commitment to efficiency and results.

• Technically skilled, you are dedicated to customer service and excel at cross-functional cooperation.

• With an educational background as a pharmacist or engineer, and experience in quality management on a pharmaceutical site, you are well-equipped to negotiate and communicate effectively in English, both verbally and in writing.

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

Pursue Progress. 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