Director of Quality Assurance (3589) Irvine, California

Salary: USD150000 - USD165000 per year

•         Develop and implement all quality programs.
•         Review and approve of company quality records.
•         Initiate, review, and approve GMP related policies and SOPs.
•         Design and conduct GMP training.
•         Interact with FDA agencies during GMP inspection.
•         Implement and monitor DEA system.
•         Support ANDA submission.
•          Provide budgetary estimation of quality-related expenses.

Physical Requirements and Working Conditions: Incumbents are subject to extended periods of sitting, standing and walking; use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; talk or hear; and taste or smell, looking at monitor, moderate noise levels and some business (international) travel. Work is performed in FDA and DEA regulated environments.