Director, Quality Control

We are looking for a Director, Quality Control to join our growing South San Francisco team!

The Director, Quality Control ensures that activities related to release, stability and in-process testing and method qualifications/validations are completed promptly as in-house and/or at Outside Testing Labs (OTL’s) associated with the manufacture of drug substance and drug product for Vaxart’s product platform technology. Responsibilities include technical review of protocols associated with method qualifications/validations, transfers, and stability studies. Strong analytical skills and prior experience in root cause analysis, deviation management and change control and other quality systems is required. Prior experience with product development activities and special studies required to support a BLA application is required. Prior experience with managing OTL’s is required. A successful candidate must possess strong understanding of cGMP requirements and ICH, FDA and other pharmaceutical industry regulatory guidelines. A strong technical understanding of biopharmaceuticals and/or vaccines is highly desired.  This position collaborates closely with cross-functional team members, including analytical development, quality assurance, manufacturing and process development, regulatory and clinical operations.

Responsibilities:

• Leads with strong leadership command, for all aspects of quality control and effectively manage employees
• Participates in all regulatory audits and inspections.
• Ensures release testing of drug substance and drug product manufactured in-house or at OTL’s meets GMP requirements and project timelines.
• Provides oversight analytical method validations/transfers for drug substance and drug product at OTL’s. Write/review method validation and transfer protocols and reports. Ensure technical and regulatory compliance.
• Provides leadership for in-house and OTL laboratory investigations related to discrepancies and deviations, OOS/OOT’s results to ensure prompt and thorough investigations.
• Periodically evaluate and propose improvements to existing analytical methods. Plan and facilitate studies to support method validation/transfer activities as required.
• Establish a system for tracking and trending release and stability data for batch analysis and shelf-life establishment.
• Maintains internal change control for validated methods and regulatory documents and assists in the change control process at OTL’s.
• Establish, monitor, and report key QC performance indicators/metrics for quality management review; use the indicators/metrics to drive operational, process and quality improvements.
• Prepare and review CMC/Quality sections of US and ex-US regulatory filings.
• Keeps abreast of industry developments and translates into corporate requirements and standards for analytical QC testing and stability programs.

Requirements:

• BS degree in Chemistry, Biochemistry, Molecular Biology, Virology or related scientific disciplines or equivalent experience, + 15 years of experience, 5 years of experience must be in Quality Control or cGMP laboratories.
• Experience with Virology, Bioassays, NGS (sequencing), Chromatography and Spectroscopic Analytical Techniques, and PCR and Molecular tools.
• Hands-on experience with method development, validation, and transfer in support of biopharmaceutical and vaccine manufacturing.
• Prior experience related to managing external OTL’s.
• In-depth understanding of CMC regulatory requirements and experience with compiling CMC sections for regulatory filings. Experience with late-stage development products a plus.
• Working knowledge of cGMP requirements, ICH, FDA, USP and other pharmaceutical industry regulatory guidelines.
• Detail-oriented with exceptional organizational, leadership and project management skills.
• Excellent written and verbal communication skills.
• Self-directed individual who can work in a fast-paced, changing yet collaborative environment.
• Must have life sciences industry background and prefer some previous “startup” company experience.

In accordance with California’s Pay Transparency law, Vaxart’s base salary range for this position is approximately $$212,000 - $240,000 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 a robust health plan, bonus program, stock options, 401(k) with employer matching, tuition assistance, and work-life balance.