Provides focus for the Quality Management Systems at Lelystad, Edelhertweg (NL) and Lyon (FR) working closely with manufacturing and other departments / functions to support, develop and promote consistency, continuous improvement and compliance with Global / Site quality and business requirements. Take initiative and drive change, including integration with the ThermoFisher Scientific Quality Systems. Develops, Improves and Maintains the Quality system for compliance to the relevant Quality systems required at the sites. Decisions and activites undertaken have both local and global implications and influence the Quality Management System and the processes and practices applied. Responsive and proactive in identifying and managing risks to assure product availability.
Acts as management representative for the three sites, and is responsible for the people development and line manager activities on a day to day basis.
Closely interacts and builds effective relationships with people across the sites to promote quality, consistency and compliance. Provides quality leadership and support to manufacturing, NPI and transfer projects. Demonstrates courage and willingness to determine appropriate action and make risk-based, sound and timely decisions. Ensures and maintains compliance with internal and external standards and regulatory requirements.
Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented. Manages corrective and preventive action system and processes ensuring the timely and accurate resolution of problems identified.
Takes responsibility for the measuring and monitoring of performance against agreed metrics. Collates and shares information/data and trending as appropriate through reports and follows up on improvement opportunities. Actively participates and/or drives EU/Global QMS improvements as required. Actively responsible for the success of the overall Quality team and the sites. Identifies, advise and implements training/coaching to meet defined Quality Systems requirements.
Responsible for the internal audit program and for hosting of external audits as required according to site and global plans. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate. Takes responsibility for ensuring timely completion and follow up through to closure.
Participates in personal development to further enhance skills and knowledge relevant to the position. Supports and maintains Company's Safety, environmental and Waste Management programme. Develops and supports personal development of individuals under the leadership.
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