• 26-May-2021 to 25-Jun-2021 (EST)
  • Quality Assurance
  • Gaithersburg, MD, USA
  • Full Time - Exempt

If you find science, speed, and success exhilarating, you have come to the right place.

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple late-stage clinical trials for NVX-CoV2373, our vaccine candidate against the virus that causes COVID-19, and has recently reported exciting and highly encouraging initial efficacy results. NanoFlu, our quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.

We are seeking a Manager/Sr. Manager who will be responsible and ready to contribute to these growing team and important programs. This individual will be a member of the Quality Assurance Team reporting into the Sr. Director Quality Assurance; and work collaboratively with internal and external teammates in all departments to develop and oversee both the global data integrity and risk management programs.

This position reports directly to the Senior Director Quality Assurance.

Responsibilities include but are not limited to:

Contribute, collaborate, develop, and oversee by:

  • Take ownership of both the global Data Integrity and Quality Risk Management policies and procedures; and drive these global programs.
  • Become the global SME to continually develop and provide Data Integrity and Risk Management guidance to all departments and sites to ensure GxP operations are conducted in compliance with applicable regulatory requirements and industry standards.
  • Assist global sites in the development of site, specific procedures to ensure that policies and procedures are current.
  • Participate with both internal and external audits to ensure compliance with current regulations.
  • Work closely with training groups to assist in the continual development of and use of relevant tools for both Data Integrity and Risk Management.
  • Provide other functions (special projects, planning, etc.) as required.
  • Occasional International travel may be required.

Minimum requirements:

  • BS/BA degree in Scientific related Studies with 8+ years of biotech or pharmaceutical experience, including experience in commercial vaccine organizations, advanced degree highly preferred.
  • Prior experience working with both global Data Integrity and Risk Management Programs.
  • In depth knowledge of regulations for Data Integrity and Risk Management, including FDA, EMA, PICs, and WHO.
  • Informal management/team lead experience.
  • Proven project manager with comprehensive planning ability.
  • High level of technical expertise in area.
  • Excellent understanding of Quality Assurance.
  • Strong communication and organizational skills.
  • The ability to represent the team cross-functionally; to apply an understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas.
  • The flexibility to strategize a new direction of his/her work when change is encountered or necessary; to help teammates with their own agility in a changing context.
  • The accountability to have others' confidence in achieving deliverables that are complex, requiring interaction with other members of the immediate team and beyond.
  • The ability to produce high-quality work on complex problems with cross-functional involvement; to anticipate and proactively prevent risks and compromises to quality.
  • The capability to recognize inefficiencies in the team and identifies improvements constructively; to work across teams effectively and frequently collaborate on larger items involving other areas. To contribute significantly to cross-functional work; to network with senior internal and external peers in own area of expertise and demonstrates leadership and ownership of issues.

Novavax is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.

Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.

Equal Opportunity Employer/Veterans/Disabled

Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.


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