The Quality Compliance Lead is responsible for leading and managing the quality compliance function to ensure adherence to regulatory requirements, GxP standards, and QMS policies.
Requirements
- Bachelorâs degree in physical sciences, Biology, chemistry, pharmaceutical sciences or a related discipline.
- Experience working in a commercial pharmaceutical manufacturing facility.
- Experience in Product Lifecycle compliance Management activities.
- Experience in performing Quality compliance activities.
- Experience applying current Good Manufacturing Practice (cGMP), U.S. Food and Drug Administration (FDA) regulations, and international regulatory requirements, including ICH Guidelines 8, 9, 10, and 11, as well as RestâofâWorld (RoW), World Health Organization (WHO), EudraLex, and Eurasian Economic Union (EEU) standards.
Benefits
- Opportunity to work with a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.