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 facilitiesProvide timely feedback to testing laboratories regarding necessary corrections to raw data and summariesPerform electronic data entry and verification Manage reference standard and critical reagent program Maintain inventory of reference standards and critical reagents at contract testing facilitiesManage the qualification and requalification of new reference standards and critical reagents Manage analytical method lifecycle Design and maintain the analytical method monitoring programRecommend improvements to existing test methodsManage the transfer of test methods to contract laboratories including review and approval of protocols and reportsParticipate in the development and validation of new test methods Initiate and review Quality System records Review deviations, OOS/OOT investigations, supplier change notices and change control records as Quality Control subject matter expertAuthor, review and revise Quality Control SOPsManage submission of Quality Control documents into electronic document management system Support regulatory filings Participate in the preparation of regulatory documents (e.g., IND, IMPD, BLA, NDA, MAA) and requests for information including data verification of contentParticipate in the preparation of Annual Product Quality Reviews including data verification of content Other duties as assigned Qualifications/Requirements Bachelor’s degree in biology, chemistry, biochemistry, microbiology, or related field6+ years in pharmaceutical/biopharmaceutical Quality Control / Analytical Science environment; experience with biologics preferredDetailed knowledge of analytical techniques and compendial methods used for testing of proteins and small moleculesProficiency in GMP analytical data reviewDemonstrated understanding of laboratory investigation methodology for OOT and OOS resultsDemonstrated knowledge of GMP principles and regulatory guidanceCompetent technical writer with expertise in authoring method protocols and reports as well as SOPs and Quality System records (deviations, investigations, change controls)Prior use of a LIMS application or electronic databaseProficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, Teams, etc.)Data-driven mindset with eye for detailRobust problem-solving abilitiesCapable of maintaining direction while working independentlyAbility to identify and adapt to changing priorities: determine what matters mostAbility to articulate issues to management in a timely mannerSelf-motivated: ability to interact with a multi-disciplinary remote-based teamEffective written and verbal communication skills Preferred Experience, Special Skills And Knowledge Previous partnership with external contract laboratory to coordinate activities between sponsor and service providerPrior author of regulatory submissions of IND, IMPD, BLA, NDA, MAAPrevious contribution to annual product quality review (APQR) process Rezolute (RZLT) currently anticipates the base salary for the Associate Director Quality Control role could range from $185,000 to $200,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate. Qualifying employees are eligible to participate in benefit programs such as: Health Insurance (Medical / Dental / Vision)Disability, Life & Long-Term Care InsuranceHoliday PayTracking Free Vacation Program401(k) Plan MatchEducational Assistance BenefitFitness Center Reimbursement We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.