Director of Quality Operations

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My Client, a start-up Biologics facility in Waterford, are looking for a Director of Quality Operations to join their team.As Director of Quality Operations, you would be is part of the quality team responsible for supporting operations at the Waterford site.The Director of Quality Operations role is responsible for leading the site quality operations team in supporting operational activities at the Waterford facility for Development and Commercial products. The successful candidate will also support and execute quality operational, strategic and team goals in order to assure the highest quality standards and regulatory compliance. As Director you will;Lead and monitor the daily operations at Contract Manufacturer(s), responsible for oversight of batch review and disposition, reviewing and approving product complaints, deviations, change controlsLead the Waterford Quality Operations team to ensure that site systems and processes and implemented and are compliant with regulatory requirementsProvide quality oversight and leadership for all development and commercial product Technical TransfersAct as a strategic leader and partner for the Waterford Site Leadership teamSupport preparation of CMC (Quality) documentation for submissions and amendments/ variationsContribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents Education and Experience;A Master's degree in a science discipline is required, with an excellent understanding of quality assurance and CMC regulatory requirements15+ years pharmaceutical experience with a very strong understanding of drug substance and drug product manufacturing processA strong understanding of, and experience in quality management is essentialThis is an excellent opportunity to join a company in start-up mode and have an influence on the strategic quality direction of the site! To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales