Job Description
**Executive Director, Quality Operations** **Job Summary:** Lead the Quality Operations organization at the Brinny site in Cork, Ireland, ensuring compliance with regulatory guidelines and standards for vaccine drug substance manufacturing and testing. **Job Description:** The Executive Director, Quality Operations, reports to the Vice President Vaccines Quality and provides strategic direction and leadership to the Brinny Site Quality Operations organization. This role is responsible for directing all quality-related functions at the site, including Quality Control (QC) testing and release, auditing, product release, environmental monitoring, and GMP compliance. **Key Responsibilities:** * Develop a strategic vision for the Quality Operations organization and ensure alignment with company goals * Manage headcount, profit plan, and capital plans for the Quality Operations organization * Ensure laboratories execute testing compliant with external regulatory guidelines, compendia, and internal GMP standards * Ensure departments have the resources needed to perform all Quality Assurance activities required to maintain product quality * Assist departmental personnel in resolution of significant Quality Assurance and Quality Control activities * Serve as a liaison with regulatory agencies during inspections * Ensure all regulatory inspection observations are addressed in a complete and effective manner * Approve Biological Product Deviation Reports for the Brinny site * Ensure capital projects and new product introductions meet regulatory and internal GMP standards * Ensure Quality Organization is compliant to safety policies and all operations are carried out in a safe manner * Work directly with plant manager on issues ranging from tactical/troubleshooting to strategic decisions * Serve on a number of management teams * Provide consultation to the VP, Vaccines Quality, on general quality issues * Represent the quality function on divisional project teams as needed * Drive a culture of Continuous Improvement by deploying the Company's Continuous Improvement System within the Quality Department * Develop an effective team by understanding their abilities, unique contribution, and broadening their skills to be agile and prepared for any future business requirements **Requirements:** * 10+ years of experience in quality and manufacturing operations * Experienced in vaccine or therapeutic protein manufacturing * Experienced in leading domestic and international health authority inspections * BSc in a related field (Biology, Chemistry, Engineering) * Advanced degree preferred * QP Qualification, desirable