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.
- 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.
- 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.