Alex Partners

Senior Director Quality

Posted: 6 minutes ago

Job Description

Our client is a leading European headquartered healthcare, manufacturing & services organisation that, having undergone significant organic and acquisitive growth, is seeking a Global Director of Quality to join and lead the business through its next stage of growth. Reporting into the COO, the newly appointed Global Director of Quality will take full ownership managing and further developing Quality Assurance and Quality Control at a local and global level.Key job responsibilities:Manage the Quality Teams of the different sites in Netherlands, Prague and USDrive the develop the global Quality processes and quality improvement programsContribute to operational and strategic decision-makingEnsure cGMP performance is measured through KPIs and compliance metricsEnsure compliance of global and site-specific quality systems with applicable laws and regulations and actual and future customer demands, including periodic review of thisLead regulatory inspections of health authorities and supports internal audits, and external audits from customersControl changes in processes to stay in compliance with laws and regulations, customer demands and product registrationsQualificationsExperience in an international cGMP environmentExperience in a senior management positionKnowledge of cGMP; expert in quality relevant regulations (e.g. ICH Q7, EU Eudralex Volume 4 regulations, 21 CFR parts 210 & 211, GAMP5, 21 CFR part 11)Experience in generating long-term strategic plansHands on mentality, data driven decision making and result orientedDutch languages skills would be preferable but not a perquisite

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