QA Director: Global Quality Systems & Compliance

Regulatory Jobs; Portage (IN); On-site; USD 140,000 - 190,000; Full time

Job summary

Aquestive seeks a Director of Quality Assurance to lead Quality Systems, Clinical Quality and Manufacturing Quality, ensuring FDA and international GMP compliance for all products from development to commercialization.

You will partner with executive leadership and cross-functional teams to drive risk management, CAPA, audits, and continuous improvement, while maintaining audit readiness and a strong quality culture; some travel required.

Qualifications

• Minimum of Bachelor’s degree required; advanced degree desirable.
• 7+ years experience in regulated GxP pharmaceutical environment.
• Directing teams and managing budgets experience.
• Strong communication and leadership skills.
• Travel required.

Responsibilities

• Oversee Quality Systems, Clinical Quality, and Manufacturing Quality for FDA and international GMP compliance.
• Provide strategic leadership for CAPA, Change Management, Audits, and Risk Management.
• Lead quality strategy across development and manufacturing, including contract manufacturers.
• Primary liaison for regulatory inspections with domestic and ex-US authorities.
• Escalate quality issues to executive leadership as needed.
• Lead relationships with suppliers, CMOs, and labs to ensure quality.
• Maintain Quality/Technical Agreements with partners and suppliers.
• Support clinical trials to ensure GCP compliance.
• Participate in Site Leadership Team for continuous improvement.
• Analyze and report quality metrics to show system health.
• Lead GxP inspection readiness across all auditable areas.
• Manage budget for Quality Assurance.

Skills

Leadership

Quality Systems

GxP

Regulatory compliance

Risk management

Project management

Communication

Strategic thinking

Budget management

Education

Bachelor’s degree

Advanced degree in chemistry/engineering/biochemistry or related science

Tools

Microsoft Office Suite

GxP documentation systems

Job description

Aquestive seeks a Director of Quality Assurance to lead Quality Systems, Clinical Quality and Manufacturing Quality, ensuring FDA and international GMP compliance for all products from development to commercialization.

You will partner with executive leadership and cross-functional teams to drive risk management, CAPA, audits, and continuous improvement, while maintaining audit readiness and a strong quality culture; some travel required.