Director, Quality Assurance
Aquestive Therapeutics
June 30, 2026
On-site
Portage, IN
Operations
Responsibilities:
- Oversee Quality Systems, Clinical Quality, and Manufacturing Quality to ensure 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 leadership for Quality Systems effectiveness (CAPA, change management, event management, supplier quality, internal audit, document management, risk management, record review/product disposition, training, field alert/recall, etc.).
- Lead quality strategy execution for development and manufacturing activities, including external GMP contract operations/labs for drug substance and drug product.
- Serve as primary contact for regulatory inspections (domestic and ex-US).
- Direct and structure communication for escalated quality issues to Executive team and/or external parties.
- Lead quality relationships with business partners, suppliers, external CMOs, and third-party testing labs; ensure adherence to Quality/Technical Agreements.
- Provide input to ensure clinical trials meet GCP regulations and internal requirements.
- Participate in Site Leadership Team to drive continuous improvement.
- Analyze/report quality metrics; lead GxP inspection strategies to maintain audit readiness.
- Coach/train/develop the function; manage succession planning; set/manage quality assurance budget with finance.
Qualifications:
- Bachelor’s degree required (advanced degree in chemistry/engineering/biochemistry or related science desirable).
- 7+ years’ experience in a regulated GxP pharmaceutical manufacturing or service-oriented laboratory.
- 2+ years in managerial role with direct reports; 2+ years overseeing direct reports.
- Strong problem-solving, strategic thinking, critical reasoning, decision-making, and communication skills.
- Proficiency with MS Word/Excel/Access/PowerPoint/Visio.
- Strong project management and organizational skills; pharmaceutical manufacturing business acumen.
- Some travel required.
Application instructions:
- Final candidate must complete a drug test and background check prior to employment.
- Oversee Quality Systems, Clinical Quality, and Manufacturing Quality to ensure 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 leadership for Quality Systems effectiveness (CAPA, change management, event management, supplier quality, internal audit, document management, risk management, record review/product disposition, training, field alert/recall, etc.).
- Lead quality strategy execution for development and manufacturing activities, including external GMP contract operations/labs for drug substance and drug product.
- Serve as primary contact for regulatory inspections (domestic and ex-US).
- Direct and structure communication for escalated quality issues to Executive team and/or external parties.
- Lead quality relationships with business partners, suppliers, external CMOs, and third-party testing labs; ensure adherence to Quality/Technical Agreements.
- Provide input to ensure clinical trials meet GCP regulations and internal requirements.
- Participate in Site Leadership Team to drive continuous improvement.
- Analyze/report quality metrics; lead GxP inspection strategies to maintain audit readiness.
- Coach/train/develop the function; manage succession planning; set/manage quality assurance budget with finance.
Qualifications:
- Bachelor’s degree required (advanced degree in chemistry/engineering/biochemistry or related science desirable).
- 7+ years’ experience in a regulated GxP pharmaceutical manufacturing or service-oriented laboratory.
- 2+ years in managerial role with direct reports; 2+ years overseeing direct reports.
- Strong problem-solving, strategic thinking, critical reasoning, decision-making, and communication skills.
- Proficiency with MS Word/Excel/Access/PowerPoint/Visio.
- Strong project management and organizational skills; pharmaceutical manufacturing business acumen.
- Some travel required.
Application instructions:
- Final candidate must complete a drug test and background check prior to employment.