Executive Director Job In Cork

A highly experienced leader is sought to oversee Quality Operations at a state-of-the-art site in Cork, Ireland, driving excellence in product quality, regulatory compliance, and operational efficiency.

The Executive Director, Quality Operations, will lead the site's Quality Operations organization, providing strategic direction and leadership to ensure the manufacture of high-quality vaccine products. Key responsibilities include: • Developing and implementing a strategic vision for Quality Operations • Managing headcount, profit plan, and capital plans for the Quality Operations organization • Ensuring laboratories execute testing in compliance with external regulatory guidelines, compendia, and internal GMP standards • Managing resources to perform Quality Assurance activities required to maintain product quality • Ensuring products released to market meet regulatory and internal standards • Resolving significant Quality Assurance and Quality Control activities, including deviation investigations and customer complaint investigations • Serving as a liaison with regulatory agencies during inspections • Ensuring regulatory inspection observations are addressed effectively • Approving Biological Product Deviation Reports for the Brinny site • Ensuring capital projects and new product introductions meet regulatory and internal GMP standards

The successful candidate will have: • 10+ years of experience in quality and manufacturing operations • Experience in vaccine or therapeutic protein manufacturing • Experience in leading domestic and international health authority inspections • BSc in a related field (Biology, Chemistry, Engineering) • Advanced degree preferred • QP Qualification, desirable