Director, Quality Assurance

Role: Director of Quality Assurance overseeing Quality Systems, Clinical, and Manufacturing Quality for Aquestive, ensuring compliance from early development through commercialization. Responsibilities: lead quality strategy, manage GMP compliance across global regulations (FDA, EU, TGA, ANVISA), oversee inspection readiness, and coordinate quality relationships with partners and suppliers. Provide strategic direction, lead audits, and manage escalation of quality issues, while driving continuous improvement and maintaining GxP compliance in drug development and manufacturing processes. Qualifications: Bachelor's degree in science or related field; 7+ years in regulated GxP pharmaceutical environments; minimum 2+ years leading teams and projects; strong problem-solving, communication, and project management skills. Preferred: advanced degrees in chemistry, engineering, or biochemistry. High-Value: experience in pharmaceutical manufacturing, GxP compliance, GMP audits, and working with external CMOs; international regulatory experience; leadership in quality systems for early to late-stage development; travel required. WorkSetup: not specified, but involvement in global inspections and partnerships suggests a collaborative, possibly hybrid environment.