Global Quality Assurance Director - Strategy & Compliance

Aquestive Therapeutics; Portage (IN); On-site; USD 100,000 - 140,000; Full time

Job summary

Aquestive Therapeutics in Portage, Indiana is seeking a Director of Quality Assurance. This leadership position is responsible for overseeing all Quality Systems, ensuring compliance with regulations including FDA and GMP. The role requires collaboration across teams and effective management of quality strategies throughout the product lifecycle.

The ideal candidate will have a minimum of 7 years of experience in a regulated GxP industry, strong leadership skills, and a Bachelor’s degree or higher in a relevant field. Responsibilities include managing quality at all manufacturing stages and interacting with regulatory authorities.

Qualifications

• 7+ years of experience in a regulated GxP industry.
• 2+ years of managerial experience overseeing direct reports.
• Strong skills in critical reasoning and decision making.

Responsibilities

• Oversee all aspects of Quality Systems for compliance.
• Lead and execute quality strategy for all manufacturing activities.
• Provide strategic direction for quality relationships with partners.

Skills

Problem solving

Strategic thinking

Project management

Interpersonal skills

Communication skills

Organizational skills

Education

Bachelor’s degree

Advanced degree in chemistry or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Visio

Job description

Aquestive Therapeutics in Portage, Indiana is seeking a Director of Quality Assurance. This leadership position is responsible for overseeing all Quality Systems, ensuring compliance with regulations including FDA and GMP. The role requires collaboration across teams and effective management of quality strategies throughout the product lifecycle.

The ideal candidate will have a minimum of 7 years of experience in a regulated GxP industry, strong leadership skills, and a Bachelor’s degree or higher in a relevant field. Responsibilities include managing quality at all manufacturing stages and interacting with regulatory authorities.