Director of Quality Assurance

About the role

The Director of Quality Assurance leads all Quality Systems, Clinical Quality and Manufacturing Quality functions at Aquestive. Reporting to executive leadership, this role ensures regulatory compliance and drives a strong quality culture across product development and commercialization.

Key responsibilities

• Oversee compliance with FDA, EU, ANVISA, TGA and other GMP regulations for all manufactured products.
• Provide strategic direction for quality systems including CAPA, change management, supplier quality, internal audit, document control, risk management and field alerts/recalls.
• Lead quality strategy for internal and external GMP contract manufacturing and laboratory activities.
• Serve as primary contact for inspections by domestic and international regulatory authorities.
• Manage escalations of quality issues and communicate with executive leadership and external parties.
• Participate in site leadership team to drive continuous improvement and audit‑ready status.
• Analyze and present quality metrics, manage budgeting and oversee coaching, training and succession planning for the QA function.

Required profile

• Bachelor’s degree required; advanced degree in chemistry, engineering, biochemistry or related field preferred.
• Minimum 7 years of experience in a regulated GxP pharmaceutical manufacturing or service‑oriented laboratory environment.
• Demonstrated ability to lead cross‑functional teams and manage complex quality programs.

Required skills

• GMP compliance (21 CFR Part 210 & 211, EU GMP Volume 4 Part 1)
• Regulatory knowledge of FDA, EU, ANVISA, TGA
• CAPA, change management, event management
• Supplier quality management and internal audit
• Document and record management, risk management
• Field alert/recall handling
• GCP compliance for clinical trials
• GxP inspection strategy