Sr. Director, Quality Assurance (QA)

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

Job summary

Vaxart is seeking a Senior Director, Quality Assurance to lead QA for clinical-stage oral tablet vaccine programs at our South San Francisco site. The role involves strategic and hands-on QA leadership across GMP manufacturing, testing, and CMC activities, with a focus on risk-based quality management and collaboration with CMC, Operations, Regulatory, and external labs.

Reporting to the CTO, this leader ensures phase-appropriate quality systems, batch release, investigations, CAPAs, and data

Qualifications

• Bachelor’s degree in scientific discipline.
• 15+ years of experience in scientific field or related.
• 10+ years of GMP QA at operations level.
• Experience across Ph 1-4 development and commercialization.

Responsibilities

• Lead QA systems for GMP operations in vaccine development and manufacturing.
• Ensure compliance with FDA/EMA/ICH and global regulations.
• Develop and monitor strategic quality plans and objectives.
• Audit programs with CDMOs, labs, and suppliers.
• Provide QA oversight of manufacturing, testing, release, and documentation.
• Review and approve batch records, changes, deviations, CAPAs, and reports.
• Drive risk-based quality decisions and cross-functional risk mitigation.
• Support regulatory submissions and inspection readiness.

Skills

GMP Quality Assurance

Regulatory inspections

Quality leadership

Risk assessment

Quality systems management

Document management systems

CQA familiarity with QMS tools

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree

Master’s degree

Tools

Veeva QMS

MasterControl

TrackWise

Job description

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.

Summary

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.

Responsibilities

• 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 identify, assess, and mitigate quality risks impacting product quality, patient safety, data integrity and supply continuity.
• Ensure risk‑based quality decisions are appropriately justified, documented and aligned with internal procedures and regulatory expectations.
• Review executed batch records and supporting documentation for lot disposition, ensuring completeness, accuracy, and compliance with cGMP requirements, and confirming that all deviations, investigations, and quality events are appropriately resolved prior to batch release.
• Support regulatory submissions, health authority questions, inspection readiness, regulatory inspections, and responses to inspection observations related to GMP manufacturing and quality systems.
• Review and approve stability protocols, reports specifications and supporting data to ensure study design, data integrity, and conclusions are scientifically sound, compliant with cGMP and regulatory expectations, and supportive of product shelf life and storage conditions.
• Oversee and implement Quality Systems to ensure compliance of cGMP activities company wide.
• Controls the issuance and revision of Standard Operating Procedures including, but not limited to, Quality Manual, Policies, Batch Records and Protocols.
• Manages the implementation and operation of a document management system.
• Drive continuous improvement of phase‑appropriate quality systems, including deviation, CAPAs, change controls, supplier quality, complaints, product disposition, and management review processes. Represent Quality with involved external regulatory and standards bodies (e.g., Food and Drug Administration, ISO assessors, etc.) when necessary to help adjudicate issues with product submissions, product performance, compliance concerns and prevailing/impending regulatory requirements.
• Prior managerial responsibility leading teams and cross‑functional work.

Requirements

• Bachelor’s degree and 15 years of experience or a master’s degree with 12+ years of experience in scientific discipline or comparable experience.
• 10+ years of experience in GMP Quality Assurance at an operational level supporting manufacturing and quality control in a pharmaceutical or biotech environment.
• Experience with all phases of development (Ph 1-4 including commercial).
• In‑depth knowledge and full understanding of GMP FDA, EMA regulations, device and combo product related guidelines, and other ICH guidelines.
• Demonstrated ability to interpret regulations, apply phase‑appropriate quality expectations, and make sound risk‑based quality decisions.
• Experience preparing for, supporting, and responding to regulatory authority inspections, partner audits and other audits.
• Hands‑on experience reviewing batch records, CoAs, deviations, investigations, CAPAs, stability documents, specifications, change controls and GMP protocols and reports.
• Strong technical writing, investigative, root‑cause analysis and risk‑assessment skills.
• Familiarity with electronic QMS platforms (e.g., Veeva QMS, MasterControl, TrackWise).
• Ability to work effectively in a small‑company, fast‑paced, matrixed environment with shifting priorities.
• Proficient in organization, prioritization, time management, and able to manage multiple priorities.
• Excellent verbal, written, interpersonal, influencing, organizational, and stakeholder‑management skills.
• Strong commitment to product quality, patient safety, compliance, scientific rigor, and attention to detail.
• Strategic thinker with a hands‑on approach and proven ability to balance long‑term quality planning with day‑to‑day execution

In accordance with California’s Pay Transparency law, Vaxart’s base salary range for this position is approximately $260,000 - $275,000 USD annually. The actual salary for this role will vary based on a variety of factors including education, job‑related knowledge, and experience. This range does not include equity, benefits, bonuses, or other non‑monetary compensation which may be included.

Vaxart offers team members a competitive compensation and benefits package, including robust health plan options, bonus program, stock options, 401(k) with employer matching, tuition assistance, commuter benefits, and work‑life balance.

Vaxart is an Equal Opportunity Employer. We are committed to the principles of equal employment opportunity for all applicants and employees. Equal opportunity and consideration are afforded to all qualified applicants and employees in personnel actions, which include recruiting and hiring, selection for training, promotion, rates of pay or other compensation, transfer, discipline, demotion, and layoff or termination. Vaxart provides equal employment opportunities without regard to race, color, religion, sexual orientation, marital status, pregnancy, gender identity, gender expression, family medical history or genetic information, citizenship, national origin or ancestry, sex, age, physical or mental disability, medical condition, veteran status, military status, or any other basis protected by law.