Sr. Manager/Associate Director, GxP QMS

Location
South San Francisco, CA
Posted
Jan 14, 2022
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

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 a Sr. Manager/Associate Director, GxP QMS to join our growing South San Francisco team!

Summary:

The Sr. Manager/Associate Director of Quality Management Systems serves as a strategic and tactical quality professional to build, manage, and administrate the company’s Quality Management System and manages Quality compliance-related activities. Principle responsibilities include system ownership of QMS, facilitating compliance in a phase-appropriate manner, developing, and overseeing the GxP audit program, and oversight of the supplier/vendor qualification program. A successful candidate reports to the Director of Quality and can interact successfully across multiple company operations.

Responsibilities:

  • Provide the strategic leadership to implement and coordinate the continuous improvement of the Quality Management System (QMS) appropriately based on phase-specific requirements for early to late-stage clinical phase CMC manufacturing.
  • Interpret US, EU, and other applicable regulatory requirements.
  • Ensures the QMS is maintained by the current regulatory compliance requirements and company objectives.
  • Evaluates the potential risk of compliance deficiencies and provides quality guidance for effective compliance.
  • Responsible for implementation of Vaxart quality systems include quality manual, quality policies, procedures, and SOP’s related to change control, deviations, CAPA, Quality Risk Management, GxP audit program, and supplier/vendor qualification.
  • Partner with Manufacturing, QC, and QA Operations to develop, review, and approval of quality-related procedures and sops.
  • Manage the supplier/vendor qualification system in support of GMP activities, including quality system interfaces with the Vaxart system.
  • Coordinate QMS (eQMS) periodic review.
  • Establish and manage metrics to track and trend the state of the QMS.
  • Plan, manage, and oversee the vendor qualification and audit program, including performing supplier risk assessments, vendor evaluation, CxO site audit, and requalification program.
  • Develop and manage the internal and external audit program.
  • Assists in coordination of response to audit findings.
  • Build and lead the Quality System and Compliance team to ensure proper quality skill sets and competencies are consistent with business needs.
  • 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. in Biological Sciences, Pharmaceutics, Engineering, or closely related field with advanced degree preferred.
  • 10+ years’ experience in the biopharmaceutical/vaccine industry include 5+ years of experience in QMS and/or compliance.
  • Comprehensive knowledge of quality systems, cGMP, regulatory, and industry standards at all phases of drug development with prior experience through commercialization.
  • Ability to think strategically, identify, prioritize, and implement actions for continuous improvement of the QMS system to meet the business needs.
  • Excellent technical writing and verbal communication skills.
  • 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 being responsible for the successful execution of tasks.
  • Ability to safely lift at least 25 pounds.

Vaccination Requirement:

Vaxart has implemented a mandatory COVID-19 vaccination policy which requires our employees to be fully vaccinated against COVID as a condition of employment. Vaxart will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. Vaxart prioritizes sound science and available facts to best ensure the ongoing safety of our employees and the community.

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

Vaxart is an Equal Opportunity Employer and values diversity. We are committed to the principles of equal employment opportunity and affirmative action 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 does not unlawfully discriminate on the basis of 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 federal, state or local law, ordinance or regulation.