The Director of Commercial Quality Assurance plays an integral role in fostering a culture of quality, efficiency, and excellence, ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy.
The focus of this position will be to support the Commercial Manufacturing Facility that is currently underway, giving the selected candidate the ability to truly be a visionary leader in the development and implementation of the Commercial Quality Assurance program. This position will provide strategic direction and guidance for the Quality Assurance functions to assure end-to-end harmonization of quality processes including risk and GMP core management, and regulatory compliance with worldwide requirements. The position is also responsible for ensuring that Quality operates in compliance within internal quality system procedures, mitigation of identified compliance and quality risks throughout product life cycle from development to commercialization for the products manufactured at Serán BioScience.