Hiring: Director, Quality Assurance Operations Company: Zevra Therapeutics Location: Boston, MA Job Posted Time: 2026-09-12 22:39:31 Target Skills & Keywords : Make About the job Required Skills: •In coordination with the Manufacturing team, assures that the serialization system for commercial distribution remains compliant, •Lead and oversee the execution of compliant administration of exception, investigation, CAPA, product complaints management systems pertaining to Zevra and vendor and operations, •Supports preparation of content and facilitates conduct of periodic Quality Management Reviews and supports preparation of annual product reviews, •Engages in the day-to-day efforts of Quality Vendor Management, •Conducts and/or facilitates internal and external (vendor) audits, self-inspections and regulatory inspection readiness meet company and applicable regulatory standards. This includes, but is not limited to, audit planning and execution, reporting and coordination with external contractors, •Supports periodic GxP training and ensure that training requirements are consistently met, as required, Qualifications: •Performs Quality review and approval of IMP and Commercial Product manufacturing documentation (e.g., master batch records, validation protocols and reports) and provides disposition of drug substance, drug product, clinical trial materials, and disposition of commercial finished goods, Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!