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Head of Quality Assurance
2 months ago
Position Overview:
In the role of Head of Quality Assurance at Aquestive Therapeutics, you will be instrumental in managing all facets associated with Quality Systems, Manufacturing Quality, and Quality Control Laboratory. Your role will involve working closely with team members and executive leadership to ensure adherence to regulations and foster a robust quality culture throughout the organization, from the early stages of development to the commercialization of products.
Primary Responsibilities:- Overseeing Quality Systems, Manufacturing Quality, and Quality Control Laboratory to meet various international GMP standards including FDA, EU, ANVISA, and TGA.
- Providing strategic direction in areas such as CAPA, Change Management, Risk Management, and Audit processes.
- Managing Quality Control Laboratory operations for stability testing and product development.
- Delivering technical assistance for method development, qualification, and validation processes.
- Leading quality initiatives for all manufacturing activities, including those involving external partners.
- Acting as the main contact for regulatory inspections.
- Building and maintaining quality relationships with business partners, suppliers, and external laboratories.
- Engaging in continuous improvement efforts at Aquestive Therapeutics.
- Supervising coaching, training, and succession planning within the quality assurance team.
Qualifications:
- A Bachelor's degree is required; an advanced degree in science or engineering is preferred.
- A minimum of 7 years of experience in a regulated GxP environment.
- Proven leadership experience with strong analytical and problem-solving abilities.
- Exceptional interpersonal and communication skills.
- Proficiency in Microsoft Office and project management tools.
- Strong business insight in pharmaceutical manufacturing.
- Willingness to travel as necessary.
This job description outlines the Head of Quality Assurance position at Aquestive Therapeutics. We are committed to fostering diversity and inclusion within our workplace.
