Manager / Sr. Manager - QA Operations

About Us:

Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are administered using convenient room temperature-stable tablets that can be stored and shipped without refrigeration.

Vaxart has demonstrated that its proprietary tablet 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. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication.

Our mission is the promotion of global health through the development of effective vaccines that can be administered by tablet rather than by injection, providing for the simple and efficient distribution and administration of safe vaccines in any setting.

We are looking for Manager/Sr. Manager - QA Operations to join our growing South San Francisco team!

* Please note that we cannot sponsor Visas at this time.

Summary:

The Manager / Sr Manager of QA Operations provides quality oversight of clinical product manufactured in Vaxart facilities, and at contract service provider. The position supports the establishment and maintenance of biologics clinical vaccination program related to the product development, product manufacturing, product testing, and material disposition. Principle responsibilities are quality oversight of manufacturing and quality control activities in Vaxart facilities, and at contract service providers; review of batch records; quality systems support; and compliance support. Quality systems support may include, but is not limited to ensuring the proper documentation, investigation, impact and risk assessments, corrective / preventive action plans, monitoring and trending. Support document control processes and systems for GxP activities in compliance with internal procedures and policies as well as regulatory requirements. The successful candidate will report to Direct of Quality as well as interact successfully across multiple disciplines and at all levels of the organization and vendors.

Responsibilities:

• Manufacturing Support may include, but is not limited to, the following:
  • Oversight and Support of both internal and external CMO GMP Manufacturing Activities.
  • Perform disposition of clinical API, API intermediates, final drug product, starting materials, and raw materials in support of Manufacturing operations.
  • Review production batch and test records and associated data for product disposition. Determines if records are within range of cGMP regulations. Reviews data obtained for compliance specifications and report abnormalities.
  • Use risk management tools to identify and assess quality related risk with recommending resolutions and implementing risk mitigation measures as needed.
  • Provide QA support for equipment/utility/facility qualification, cleaning validation, process development and characterization, process validation.

• Quality Support:
  • Responsible in building and improving quality systems.
  • Control and execution of Deviations.
  • Corrective/Preventive Action (CAPA) plans.
  • Out-of-Specification/Out-of-Trend (OOS/OOT) results
  • Nonconforming materials.
  • Environmental monitoring excursions.
  • Clinical and/or commercial CMO selection and management.
  • Support for Quality Risk Management Program.
  • Support for product quality and management metrics review processes.

• Compliance support may include, but is not limited to, the following:
  • Internal and external audits
  • Preparation and support for internal audits

• Ability to problem solve, think critically, and troubleshoot while working independently.
• Participate, observe, and/or monitor day to day quality operations.
• Ensure accurate and timely resolution of quality related activities.
• Communicate issues and assess their impacts and collaborate with others to resolve/mitigate those issues.
• Update management on activities as well as provide input and recommendations as appropriate.

Requirements:

• B.S. or higher in Biological Sciences, Pharmaceutics, Engineering, or equivalent work experience.
• Minimum of 3+ years of Quality Assurance experience, with total 8+ years of experience in the biopharmaceutical/vaccine industry.
• Comprehensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization.
• Experience and/or knowledge of process validation lifecycle approach for biological product is preferred.
• Practical knowledge and understanding of implementing phase appropriate procedures and processes. Able to make appropriate risk-based assessments and decision based on phase-specific requirements for early to late-stage clinical phase CMC manufacturing.
• Demonstrated ability to work and communicate collaboratively with other independent workers and to train workers in new procedures, as necessary.
• Must have strong critical thinking skills, initiative, integrity, and strong interpersonal and leadership skills. The ability to communicate clearly and precisely, both orally and in writing, is essential. Highly motivated, able to multi-task, strict attention to detail and open to be responsible for successful execution of tasks.
• Ability to safely lift at least 25 pounds.