Director, Quality Assurance
Aquestive Therapeutics
August 24, 2026
Remote friendly (Portage, IN)
United States
Operations
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 (CAPA, Change Management, Event Management, Supplier Quality, Internal Audit, Document Management, Risk Management, Record Review and Product Disposition, Training, Field Alert/Recall, etc.).
- Lead and ensure execution of quality strategy for all development and manufacturing activities, including external GMP contract manufacturing operations and laboratories for drug substance and drug product.
- Serve as primary contact for inspection interactions with domestic and ex-US regulatory authorities.
- Direct escalated quality issues, determining need for escalation to Executive team and/or external parties.
- Lead strategic quality relationships with business partners, suppliers, external CMOs, and third-party testing laboratories.
- Ensure adherence to Quality/Technical Agreements with business partners and suppliers.
- Provide input to ensure clinical trial activities comply with GCP and internal requirements.
- Participate in Site Leadership Team to drive continuous improvement.
- Analyze, report, and present relevant metrics to show health of systems.
- Lead GxP inspection strategies to maintain audit-ready status.
- Coach, train, develop, and plan succession for the function.
- Set, manage, and monitor Quality Assurance budget with Finance.
Qualifications:
- Minimum Bachelor’s degree required; advanced degree in chemistry, engineering, biochemistry, or related science desirable.
- 7+ years in a regulated GxP industry in pharmaceutical manufacturing operations or a service-oriented laboratory.
- Demonstrated ability to direct a function, oversee projects/teams; 2+ years overseeing direct reports.
- 2+ years in a managerial role with direct reports.
- Strong problem solving, strategic thinking, critical reasoning, and decision making.
- Strong interpersonal and verbal/written communication skills.
- Excellent computer skills (e.g., Microsoft Word, Excel, Access, PowerPoint, Visio).
- Strong project management and organizational skills to deliver on time and on budget.
- Strong business acumen in pharmaceutical manufacturing.
- Some travel required.
- 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 (CAPA, Change Management, Event Management, Supplier Quality, Internal Audit, Document Management, Risk Management, Record Review and Product Disposition, Training, Field Alert/Recall, etc.).
- Lead and ensure execution of quality strategy for all development and manufacturing activities, including external GMP contract manufacturing operations and laboratories for drug substance and drug product.
- Serve as primary contact for inspection interactions with domestic and ex-US regulatory authorities.
- Direct escalated quality issues, determining need for escalation to Executive team and/or external parties.
- Lead strategic quality relationships with business partners, suppliers, external CMOs, and third-party testing laboratories.
- Ensure adherence to Quality/Technical Agreements with business partners and suppliers.
- Provide input to ensure clinical trial activities comply with GCP and internal requirements.
- Participate in Site Leadership Team to drive continuous improvement.
- Analyze, report, and present relevant metrics to show health of systems.
- Lead GxP inspection strategies to maintain audit-ready status.
- Coach, train, develop, and plan succession for the function.
- Set, manage, and monitor Quality Assurance budget with Finance.
Qualifications:
- Minimum Bachelor’s degree required; advanced degree in chemistry, engineering, biochemistry, or related science desirable.
- 7+ years in a regulated GxP industry in pharmaceutical manufacturing operations or a service-oriented laboratory.
- Demonstrated ability to direct a function, oversee projects/teams; 2+ years overseeing direct reports.
- 2+ years in a managerial role with direct reports.
- Strong problem solving, strategic thinking, critical reasoning, and decision making.
- Strong interpersonal and verbal/written communication skills.
- Excellent computer skills (e.g., Microsoft Word, Excel, Access, PowerPoint, Visio).
- Strong project management and organizational skills to deliver on time and on budget.
- Strong business acumen in pharmaceutical manufacturing.
- Some travel required.