POSITION SUMMARY: The Director, Quality is responsible for providing quality team and function oversight in the Rochester site for both the production and research and development (R&D) labs. The Director, Quality is responsible for strategy leadership, Quality Management System (QMS) implementation and management, leadership of the quality team, and providing assurance for compliance with applicable regulations, laws, and guidelines. PRINCIPAL RESPONSIBILITIES: Develop and maintains high performing quality organization aligned with business goals and leads staff development in alignment with Nucleus RadioPharma strategic goals, quality objectives, and operational systems with oversight from and in support of the Vice President, Quality and Leadership Team. Serves as a positive ambassador of the Quality Assurance (QA) organization, demonstrating a strong service mindset towards both internal stakeholders and external customers. Acts as a champion for continuous improvement within the QMS through a well-trained workforce, streamlined business processes and appropriated structured quality operations. Provide expertise and guidance in quality matters. Establishes, maintains, oversees, and ensures effectiveness of quality programs and documentation to assure compliance with regulations and procedures. Develops short and long-term plans to achieve both quality and business objectives. Leads a team of quality professionals including objective setting, performance management, coaching, training, development, and recruiting. Oversees and executes the audit program for internal system/in-process audits and sponsor related study audits. Develop and implement risk management strategies to identify and mitigate quality risks throughout the product lifecycle. Provides oversight and resource for external vendors quality programs as required. Serves as a Subject Matter Expert (SME) and in-house advisor on compliance. Manages QA oversight of deviations, quality issues, CAPAs and product complaint investigations. Creates, maintains and assures that appropriate Quality Management Documents are in place and optimally maintained to support the critical drug development activities. Ensures training and education are adequate and appropriately provided, including development and delivery of training materials as needed. Defines and reports key quality and compliance metrics to proactively identify emerging trends to ensure continuous improvement and compliance. Oversee the qualification, evaluation, and monitoring of suppliers to ensure they meet the company's quality standards. Reports quality compliance activities and findings to leadership on a regular basis Manage the quality department's budget, ensuring efficient allocation of resources to meet quality goals. Performs other duties as assigned.