• 01-Jun-2021 to 01-Jul-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 QA Documentation Manager to join our Quality Assurance Department.

This position reports directly to the Associate Director, Quality Systems and this position may require periodic weekend/evening work.

Responsibilities include but are not limited to:

  • Design, deployment and continuous improvement of Novavax Document Management Program
  • Create, track and present metrics related to the Document Management Program for Senior Management
  • Participate in regulatory inspections and maintain a state of inspection readiness
  • Maintain working knowledge of Novavax Documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
  • Performs lead role on complex issues with minimal input from senior staff
  • Management of staff
  • Other duties as assigned

Minimum requirements:

  • Bachelor's degree preferred
  • 8+ years of Quality experience in pharmaceutical, biologics and/or vaccine manufacturing
  • Minimum of 2 years supervisory experience
  • Knowledge and expertise in principles and practices of current Good Manufacturing Practices (cGMP)
  • Demonstrated verbal and written skills in communicating regulatory and technical information
  • Solid organizational and time management skills, proven project management, presentation, and facilitation skills.
  • Preferred:
    • Biotechnology experience preferred.
    • Innovation including looking internally and externally for best practices.
  • Advanced proficiency in Windows-based software and word processing experience

Additionally, we prefer candidates that have:

  • The ability to clearly communicate and represent the team cross-functionally
  • The ability 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 ability to influence a prompt and constructive response of the team when change is encountered or necessary.
  • The ability to apply perspective to lead more junior teammates and cross-functional partners through change
  • The ability to demonstrate confidence in achieving complex deliverables requiring cross-functional involvement
  • The ability to produce high-quality work on complex problems with cross-functional impact.
  • The ability to take ownership of quality considerations and standards across the team's work product
  • The ability to frequently mentor more junior team members.
  • The ability to frequently work cross-functionally as the representative for their area and may lead cross-functional work.
  • The ability to contribute work outside their own area of expertise.
  • The ability to network with key contacts outside own area of expertise and mentor peers and senior team members within the team
  • The ability to model, lead, train, and motivate multiple levels of employee to be exceptional collaborators

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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