We are looking for our Manager of Quality Management System for the Quality Assurance Consumables Technologies (CT)' Team. This position is available at our offices in Aubagne.
Based on orientation provided by the manager of Quality Assurance, you the Operations Unit (OU) quality management system. Your main focuses are to steer the OU quality governance model, to own quality system processes and to lead and coordinate networks with the sites and with the other OUs on quality system topics.
Grow with us - Your Responsibilities
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Drive the quality management system of OU Global Teams
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Drive the consistency and the compliance of the Quality System at OU Level and cross-sites :
- Coordinate the QMS related processes definition et continuous review
- Be the partner and the relay of sites and global QMS functions in BPS.
- Advise sites to maintain quality system compliance to applicable regulatory requirements and standards.
- Lead QMS network to create synergies, to share best practices, to improve and continue to build harmonization.
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OU process owner of core quality processes: CAPA, Audit, Document Management, Change Management
- Coordinate the cross-OU network to define and optimize the processes design with respect of mandatory guidelines and operational needs.
- Coordinate the process implementation.
- Define the process governance: define key metrics and routine to analyze and enhance the process performance.
- Analyze data (eg. KPI) to identify trends, risks and manage related corrective and preventive actions.
- Be the link between the sites and global functions to influence on necessary changes to support sites’ needs.
- Identify gaps/ opportunities in quality processes and lead adequate improvements, standardization, and harmonization projects.
- Lead the network among site quality teams to create synergies, to share best practices, to build harmonization, to enhance data analysis, to instill good practices.
What will convince us
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Engineer or master’s degree in engineering or biotechnology
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Minimum 8 years’ experience in a leading position in operational quality management.
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Experience in pharmaceutical industry and/or medical device industry preferred
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Experience with Change Management in a regulated environment
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Experience in a multisite company
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Strong risk assessment & problem-solving knowledge
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Strong capacity to assess the situations and analyze data
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Strong analytics approach
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Project Management
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Fluent in English
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Knowledge of ISO 9001 or similar standards
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers
Top Skills
What We Do
Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing.
We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide.
With innovative laboratory instruments and consumables, the our Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes.
The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically.
Based in Göttingen, Germany, Sartorius also has a strong global reach with around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies.
In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe.
Join our team, partner or collaborate with us.
