Position: Manager of Quality Assurance
Manager of Quality Assurance Summary:
Responsible for the establishment and management of the company's Quality Systems to ensure that drug development, registration, and commercialization activities are compliant with all applicable regulatory requirements and guidelines.
Essential Duties
- Develop and manage GMP quality and compliance systems and policies.
- Oversee day-to-day activities of the QA group and GMP documentation.
- Ensure compliance with internal policies, regulations, and expectations.
- Establish quality plans, strategies, and objectives for the site.
- Inspire transformative thinking and motivate employees for benchmark performance.
- Chair the site quality management review board and share best practices.
- Monitor and develop quality performance metrics.
- Foster continuous improvement across functions and systems.
- Lead internal and external GMP audits and vendor qualification.
- Provide oversight for manufacturing batch review and DEA controlled substances.
Qualifications
- Bachelor's degree in chemistry, biology, or related field.
- 10+ years of GMP quality experience.
- Minimum 2 years of supervisory/management experience.
- Extensive technical expertise in pharmaceutical analysis and development.
- Strong communication and project management skills.
- Knowledge of cGMP regulations, ICH guidelines, and controlled substances.
