Quality Manager for Microbiology Manufacturing (m­­/­­f­­/­­d)

Provide leadership and management for quality activities at the Microbiology manufacturing site in Wesel (Germany) to ensure that quality assurance, quality systems, product performance testing and quality engineering activities are effective, efficient and in compliance with regulatory expectation and quality standards. A day in the Life: Responsible for compliance to mandatory regulatory requirements including Quality Management Systems standards i.e. DIN EN ISO 9001, DIN EN ISO 13485; DIN EN IEC 17025, FDA and the In Vitro IVDD, IVDR Drive continuous improvement through PPI to deliver improved performance from a quality, service and cost point of view. Responsible for the release of product to external and internal acceptance criteria. Set clear comprehensive expectation demonstrate role model leadership; provide meaningful, timely feedback about performance, train and mentor to continuously improve individual performance and business results Prepare and monitor site quality objectives and provide metrics and quality input to the Site Senior Leadership team and the Divisional QRA function Prepare the site for, and host external audits (customer/regulatory) ensuring corrective/preventative action are put in place to address non-conformances. Drive, champion and promote quality practices and behaviours across the site. Lead and develop staff within the function to a high level of competency and performance. Key repsonsibilites: Responsible for compliance to mandatory regulatory requirements including Quality Management Systems Manage fundamental quality system process to ensure compliance, timeliness and effectiveness e.g. CAOA, change control, audit, management review, supplier control, etc. Ensure that all customer complaints are reviewed in a timely manner and escalated appropriately through the vigilance process where required, including notification of reportable events to regulatory authorities. Prepare the site for, and host external audits (customer/regulatory) ensuring corrective/preventative action are put in place to address non-conformances. Review ongoing development of the Quality System to ensure and improve its effectiveness through ownership of the management review process. Lead the quality engineering team ensuring partnership with the Operations teams on production issues, training and SOP compliance, root cause analysis, CAPA implementation and other Quality related matters