Director of Quality
- Responsible for managing quality assurance and quality compliance support for manufacturing operations.
- Develop, implement, and manage batch record review and batch release processes for contract manufacturers.
- Optimize and manage Change Control System in compliance with cGMPs and other regulations.
- Participate in CTP Premarket Tobacco Application (PMTA) process including writing and reviewing protocols, application documents, and study reports.
- Conduct Annual Product Reviews to verify Quality Status.
- Identify, implement, and maintain Quality and Compliance Document Management System.
- Participate in Quality and Compliance Vendor Management activities including audits and site-visits.
- Maintain SOPs and oversee change controls, deviations, batch records.
- Participate in grant applications, reports, and progress updates.
- Bachelor's in biology, Chemistry, and other relate fields OR MBA plus 15 years of experience.
- Experience in a GMP regulated environment.
- Supervisory Experience.
- Must be able to review investigations, batch records, change controls, etc..
- Knowledge of international regulations