Senior Director, QA — GMP Compliance & Strategy

Vaxart, Inc.; South San Francisco (CA); On-site; USD 260,000 - 275,000; Full time

Benefits offered by this job

Health plan options

Stock options

401(k) with employer matching

Tuition assistance

Job summary

Vaxart, Inc. is seeking a Senior Director, Quality Assurance to lead the QA strategy for clinical‑stage oral vaccine programs at the South San Francisco site.

This onsite leadership role ensures phase‑appropriate quality systems across manufacturing, testing, release and supply of investigational products. The role partners with CMC, Regulatory, Quality Control, Clinical Supply and external CDMOs to safeguard product quality, patient safety and data integrity while enabling timely decisions and

Qualifications

• Desirable regulatory knowledge across FDA/EMA and ICH guidelines.
• Experience aligning QA with GMP manufacturing and testing.
• Experience preparing for regulatory inspections and audits.

Responsibilities

• Lead QA for GMP operations across development and manufacturing.
• Review and approve batch records, deviations, CAPAs, and GMP docs.
• Coordinate audits, supplier qualification, and regulator inspections.
• Ensure data integrity and patient safety through risk-based QA decisions.
• Collaborate with CMC, Regulatory, and external labs to manage quality risks.
• Maintain quality systems and document management for compliance.
• Oversee release of clinical supplies and related QC activities.

Skills

GMP QA

Regulatory inspections

Risk-based decisions

Quality systems

Document control

Quality metrics

Cross-functional leadership

Auditing

Education

Bachelor’s degree in a scientific discipline

Master’s degree in a related field

Tools

Veeva QMS

MasterControl

TrackWise

Job description

Vaxart, Inc. is seeking a Senior Director, Quality Assurance to lead the QA strategy for clinical‑stage oral vaccine programs at the South San Francisco site.

This onsite leadership role ensures phase‑appropriate quality systems across manufacturing, testing, release and supply of investigational products. The role partners with CMC, Regulatory, Quality Control, Clinical Supply and external CDMOs to safeguard product quality, patient safety and data integrity while enabling timely decisions and