Executive Director - Site Quality Head, Brinny

Executive Director, Quality

This role will be based on-site at Brinny, in Cork, Ireland.

Purpose of Role:

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. Directs all quality related functions at the site including Quality Control (QC) testing and release, auditing, product release, environmental monitoring, and GMP compliance for vaccine drug substance manufacturing/testing and vaccine drug product testing. Ensures that products are manufactured in compliance with all regulatory guidelines and standards and facilities innovation and continued improvement. Employs risk management based on scientific knowledge and protection of the patient.

 Activities Within Role include:

• Provides direction and leadership to the quality leaders of the manufacturing areas, laboratories, and quality assurance of the Brinny Vaccines Manufacturing Site. Key activities include developing a strategic vision, managing headcount, profit plan and capital plans.
• Ensures that the laboratories execute testing compliant with external regulatory guidelines, compendia, and internal GMP standards. This includes testing programs for raw materials, in-process materials, drug substance, and drug product.
• Ensures that the departments have the resources needed to perform all Quality Assurance activities required to maintain product quality.
• Ensures that all products released to the market are manufactured within regulatory and internal standards.
• Assists departmental personnel in resolution of any significant Quality Assurance and Quality Control activities, including deviation investigations, customer complaint investigations, and issuance of regulatory notifications.
• Serves as a liaison with regulatory agencies during inspections. Ensures that all regulatory inspection observations are addressed in a complete and effective manner.
• Is responsible for approving all Biological Product Deviation Reports for the Brinny site
• Ensures capital projects and new product introductions meet regulatory and internal GMP standards.
• Ensures Quality Organization is compliant to safety policies and all operations are carried out in a safe manner.
• Works directly with plant manager on issues ranging from tactical/troubleshooting to strategic decisions.
• Serves on a number of management teams. Provides consultation to the VP, Vaccines Quality, on general quality issues. As needed, represents the quality function on divisional project teams.
• Responsible for driving a culture of Continuous Improvement by deploying the Company’sContinuous 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

The successful candidate will have the following skills and experience:

• 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.
• Preferred:
• Experience in site-based manufacturing and quality operations managerial roles, experience at multiple sites.
• BSc in related field (Biology, Chemistry, Engineering). Advanced degree preferred.
• QP Qualification, desirable