Sr. Director, Quality Assurance; QA)

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications.

Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune‑oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.

We are looking for a Sr. Director, Quality Assurance (QA) to join our South San Francisco team. This is an onsite position in our South San Francisco Office.

The Senior Director, Quality Assurance provides strategic and hands‑on QA leadership for Vaxart’s clinical‑stage oral recombinant tablet vaccine programs and related GMP manufacturing, testing, and CMC activities. Reporting to the Chief Technology Officer, this leader is responsible for implementing and maintaining phase‑appropriate quality systems that support compliant development, manufacture, testing, release, and supply of Vaxart’s investigational products.

In this role, the Senior Director, Quality Assurance applies a risk‑based approach to prioritize QA support for GMP operations, including review and approval of executed batch records, deviations, analytical data, stability data, change controls, CAPAs, specifications, protocols and reports, and other GMP documentation. The role partners closely with CMC, Technical Operations, Quality Control, Regulatory, Clinical Supply, and external CDMOs/contract laboratories to identify and elevate compliance risks, enable proactive decision‑making, and ensure product quality, patient safety, data integrity, and supply continuity.

This position focuses on GMP quality assurance and does not include clinical quality oversight for clinical studies or clinical data.

• Lead implementation and day‑to‑day execution of Vaxart’s GMP quality management systems supporting oral recombinant tablet vaccine development and manufacturing.
• Ensure compliance with applicable FDA, EMA, ICH and other global GMP regulations, standards, internal policies, and procedures.
• Develop, implement, and monitor progress against Vaxart’s strategic quality plan, quality objectives, projects, and goals in alignment with CMC and program priorities.
• Conducts and supports internal and external audits, GMP supplier qualification activities including CDMOs, contract testing laboratories, raw material suppliers, and other contractors.
• Provide QA oversight of GMP manufacturing, analytical testing, stability, labeling, packaging and release of clinical supplies for investigational oral tablet vaccine products.
• Review and approve Master Batch Records (MBRs), executed batch records, specifications, protocols, reports, change controls, deviations, investigations, CAPAs, and related documentation to ensure accuracy, completeness, data integrity and cGMP compliance.
• Review and approve laboratory investigations (OOS/OOT/deviations) conducted by internal or external laboratories ensuring thorough root cause analysis, robust corrective and preventative actions (CAPA), and aligned decision‑making impacting product quality and disposition.
• Partner with cross‑functional teams to…