This position is responsible and accountable for the execution of all activities associated with the Quality Unit (Quality Assurance and Quality Control) at either of the Immunotherapy Manufacturing Facilities (IMF) to ensure patient safety. The role ensures the site, process, product, and personnel are compliant with all applicable regulatory requirements. It is a key partner to all Executive Quality and Operations Leadership to ensure FDA readiness. This role is a key strategic quality leader and needs substantial experience in GMP operations, regulatory inspections, internal and external audit, and excellent verbal and written communication skills.
Directs overall operational leadership in planning and management of quality systems and activities, including resource management and vendor management, which includes the following:
Implements corporate Quality policies ensuring finished products conform to company standards and satisfy GMP regulations.
Contributes to Quality department strategic management.