Director, Quality Assurance; Operations

About Zevra Therapeutics, Inc.

We are a rare disease therapeutics company leading with science to make life‑changing therapeutics available to patients with significant unmet needs. We involve key thought leaders, physicians, patients, care partners, and advocacy groups in all of our clinical and regulatory development strategies. With a keen understanding that drug development often requires creative solutions, we have the insight and expertise to forge new pathways to success that others have missed.

By following the data without bias, our transparent narratives and common‑sense perspective have successfully overcome complex development challenges to make much‑needed therapies available to patients. Nimble and dauntless, we push boundaries beyond what is thought to be possible and advance new therapies that have the potential to bring meaningful improvement to patients’ lives.

The Director of Quality Operations has a critical role within Zevra that will provide technical leadership for the administration of Zevra’s Quality Management System (QMS). The position is responsible for improving Zevra’s QMS and supporting operational processes. This position is further responsible for assuring that all development and commercial operations carried out by Zevra and its contractors consistently comply with Zevra standards and applicable regulations.

Key attributes of the incumbent include enthusiasm for building lasting organizational systems suitable capable of growing with the organization. The qualified candidate must have experience building and maintaining sustainable and trusting cross‑functional relationships with key strategic internal and external stakeholders. The incumbent must rapidly earn a strong reputation supporting programs from preclinical through commercialization stages. This position requires close cross‑functional teamwork, an ability to understand and communicate risk, and a desire to coach and develop cross‑functional staff.

• 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
• In coordination with the Manufacturing team, assures that the serialization system for commercial distribution remains compliant
• Responsible for 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
• In collaboration with Head of Quality and other department heads, prepare, review, approve, and implement SOPs as required
• Responsible for Quality Review Boards, providing technical expertise for product quality decisions
• Responsible for manufacturing investigations, in collaboration with the Manufacturing Team, ensuring appropriate corrective and preventive actions are taken as required
• Support continuous improvement initiatives to optimize Zevra’s quality and compliance position
• Cross‑train and serve as back‑up for Quality Systems, as assigned

• 10+ years of progressive experience in pharmaceutical/biotech industry with expertise in establishing effective and efficient systems and processes supporting pre‑clinical, clinical and commercial programs
• 7+ years of Quality leadership experience with a successful track record in vendor oversight and managing relationship with external stakeholders as well as internal QA systems in a virtual environment
• 7+…