Associate Director, Quality Control

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy, RZ358 (ersodetug), is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI) Position Description This position is responsible for management of Rezolute ’s clinical and commercial product testing program. The Associate Director, Quality Control acts as a liaison between Rezolute and its contract test laboratory (CTL) / CMO partners who perform our release and stability testing. The successful candidate will support Rezolute ’s objectives by acting as a Quality Control subject matter expert during internal stakeholder collaborations and external team meetings. Principle Duties and Responsibilities Include: Manage data review program Review raw data and data summaries provided by contract testing facilities Provide timely feedback to testing laboratories regarding necessary corrections to raw data and summaries Perform electronic data entry and verification Manage reference standard and critical reagent program Maintain inventory of reference standards and critical reagents at contract testing facilities Manage the qualification and requalification of new reference standards and critical reagents Manage analytical method lifecycle Design and maintain the analytical me