QMS 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 Services by acting as a central organization.

Our Team:

Transformation of 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.

About the job:

As a QMS Expert You contribute to the execution of quality related processes 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. 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 Batch release, digitalized forms at shopfloor, deviations, CAPAs, change controls etc.).

Main responsibilities will include one or more among the followings:

• Managing Batch release, bath recall and quality defect notification in the Quality Management System (QMS) to ensure compliance, efficiency, and effectiveness
• Quality risk management and quality event escalation using Quality processes
• Handling deviations as well as corrective and preventive actions providing operational support and troubleshooting
• Ensuring consistent use of the content management system across teams and aligning it with real business needs
• Overseeing change controls and risk management in collaboration with stakeholders
• Ensuring successful execution of total productive maintenance and audit related tasks in QMS.
• Tracking the success of implemented solutions and measuring their impact using defined key performance indicators (KPIs)
• Focusing on compliance, planning, and operational excellence at all levels

In this role, you will help transform Quality operations into streamlined, efficient, and digitalized systems, making a meaningful impact on how processes are managed across the organization.

About you

• Experience:
  • 5+ years in pharmaceutical industrial Quality operations, with hands-on QMS experience

• Technical skills:
  • Expertise in project management within GxP-regulated environments
  • Strong interest in digital projects and technologies
  • Solid knowledge of computer system validation and digital solutions in GxP contexts
  • Action-oriented, results-driven mindset with a focus on patient outcomes
• Soft skills:
  • Team player with excellent listening and collaboration skills
  • Persuasive, adaptable, and able to drive change
  • Results-focused and proactive
• Education: Technical/scientific education, data management
• 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

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!