Manager of Quality Management System FH
Manager of Quality Management System FH
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Job Description
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
Drive the quality management system of OU Global Teams
Drive the consistency and the compliance of the Quality System at OU Level and crosssites :
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.
OU process owner of core quality processes: CAPA Audit Document Management Change Management
Coordinate the crossOU 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
Engineer or masters degree in engineering or biotechnology
Minimum 8 years experience in a leading position in operational quality management.
Experience in pharmaceutical industry and/or medical device industry preferred
Experience with Change Management in a regulated environment
Experience in a multisite company
Strong risk assessment & problemsolving knowledge
Strong capacity to assess the situations and analyze data
Strong analytics approach
Project Management
Fluent in English
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 realworld 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/careers
Required Experience:
Manager
Employment Type
Full-Time
