Director, Quality Assurance

Leadership role overseeing all aspects of Quality Systems, Clinical Quality, and Manufacturing Quality for Aquestive, ensuring compliance and fostering a strong quality culture across the organization for products from early-phase development to commercialization.

Responsibilities

• Oversee all aspects of Quality Systems, Clinical Quality, and Manufacturing Quality to assure compliance with FDA, EU, ANVISA, TGA, and other international GMP requirements (e.g., 21 CFR Part 210 + 211, EU GMP Volume 4 Part 1).
• Provide strategic direction and leadership to ensure effectiveness of Quality Systems (e.g., CAPA, Change Management, Event Management, Supplier Quality, Internal Audit, Document Management, Risk Management, Record Review and Product Disposition, Training, Field Alert/Recall).
• Lead and ensure execution of quality strategy for all development and manufacturing activities, including external GMP contract manufacturing or laboratories for drug substance and drug product.
• Serve as primary contact for all inspection interactions with domestic and ex-US regulatory authorities; provide direction for escalated quality issues and determine communication needs for further escalation to the Executive team or external parties.
• Lead strategic quality relationships with business partners, suppliers, external CMOs, and third-party testing laboratories; ensure adherence to Quality/Technical Agreements.
• Provide input to ensure clinical trial activities comply with GCP regulations and internal requirements.
• Actively participate in the Site Leadership Team to drive continuous improvement initiatives.
• Analyze, report, and present metrics to demonstrate the health of systems.
• Lead GxP inspection strategies to maintain an audit-ready status across all auditable areas.
• Manage coaching, training, development, and succession planning for the Quality Assurance function.
• Set, manage, and monitor the Quality Assurance budget in conjunction with finance.

Requirements

• Minimum of a Bachelor’s degree; advanced degree in chemistry, engineering, biochemistry, or related science field desirable.
• Minimum 7+ years of related work experience in a regulated GxP industry within pharmaceutical manufacturing or a service-oriented laboratory.
• Demonstrated ability to direct a function, oversee projects, and lead teams; minimum 2 years of experience overseeing direct reports.
• Minimum 2+ years in a managerial role with direct reports.
• Strong problem-solving, strategic thinking, critical reasoning, and decision-making skills.
• Excellent interpersonal, verbal, and written communication skills.
• Proficient in Microsoft Office (Word, Excel, Access, PowerPoint, Visio).
• Strong project management and organizational skills to maintain productivity, innovation, and priority-setting.
• Strong business acumen in pharmaceutical manufacturing.
• Some travel required.

Final candidate will be required to complete a drug test and background check prior to employment. Aquestive is a drug-free workplace.