Director, Quality Assurance

Role: Senior leadership position overseeing Quality Assurance functions for pharmaceutical development and manufacturing at Aquestive, spanning early phase to commercialization. Responsibilities: direct global Quality Systems, Clinical and Manufacturing Quality, ensuring compliance with FDA, EU, and other international GMP standards; lead quality strategy, inspection readiness, and risk management; manage external relationships with CMOs and testing labs; contribute to continuous improvement initiatives; oversee audits, regulatory interactions, and compliance metrics; manage team development and budget. Requirements: Bachelor's degree in science/engineering; 7+ years in a regulated GxP pharmaceutical environment; 2+ years in managerial roles with direct reports; strong problem-solving, strategic thinking, and communication skills; proficiency in GxP regulations, quality systems, and project management. HighValue: pharmaceutical manufacturing, GxP compliance, GMP standards, global regulatory interactions, quality systems leadership, team management, budget oversight. WorkSetup: not specified; travel required.