Quality Assurance Manager
- Location: Greenville, SC
- Working situation: Hybrid
- Level: Manager
The Quality Assurance Manager will:
- Assist in the development, implementation, and maintenance of quality systems, including SOPs, batch records, and documentation control.
- Develop, implement, and maintain the quality management system in accordance with relevant regulations and industry standards.
- Conduct internal audits to ensure compliance with cGMP regulations and company policies.
- Oversee the execution of quality activities, including batch record review, product release, and investigations into deviations or non-conformances.
- Support investigations of non-conformances, deviations, and customer complaints, and assist in the implementation of corrective and preventive actions.
- Assist in the preparation and review of regulatory submissions and responses to regulatory agencies.
- Serve as the primary point of contact for quality-related matters, both internally and externally, fostering effective communication and collaboration across departments and with clients.
The Quality Assurance Manager has the following qualification:
- Bachelor's degree in a Life Sciences or engineering discipline.
- 5+ years of experience in quality assurance within the biotech or pharmaceutical industry.
- In-depth knowledge of cGMP regulations, ICH guidelines, and other relevant quality standards.
- Previous experience is a CMO (contract manufacturer) environment.
- Certified Quality Auditor (CQA) or similar certification is a plus.
- Ability to work effectively in a fast-paced environment and manage multiple priorities.
If you are interested in the role of Quality Assurance Manager, don't hesitate to apply today!
