Manager of Change Control

il y a 1 jour


Aubagne, France Sartorius Temps plein

We are looking for our Manager of Change Control for the Quality Assurance Consumables Technologies (CT)' Team. This position is available at our offices in Aubagne.

In this role, your main focus is to coordinate the definition and continuous improvement of a change control process that fits to operational needs and mandatory guidelines.

**Grow with us - Your Responsibilities**
- Coordinate the cross-OU network to define and optimize the process 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.
- Is the link between the sites and OU 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.
- Drive multi-site improvement actions and harmonization projects.
- Contribute to specific negotiation & communication as required (customer, other Sartorius organization such as Sales/BA etc.).
- Support Data management diverse initiatives and projects
- Key user of Product Life Cycle Management tool
- Drive the global changes coordination

**What will convince us**
- Engineer or master’s 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 & problem-solving 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


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