Associate Director, Quality Operations


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Gaithersburg, MD

Job Description

As posted by the hiring company

Job Overview:

**Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.**

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

Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases.  We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform.  Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.

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

We are seeking an Associate Director, Quality Operations Internal to join our Quality Assurance department in Gaithersburg, MD. The Associate Director, Quality Operations (Internal) will serve as the leader and operational manager to direct, oversee, and manage all quality assurance operations activities for Novavax, Inc as it relates to Virus Stock, Cell Bank and Drug Substance manufacturing and testing at the Gaithersburg, MD campus. Responsibilities include GMP/PAI Inspection Readiness Management, ensuring oversight of batch manufacturing, Novavax process/documentation/facility related change management execution and issue management, Virus Stock, Cell Bank and Drug Substance release for Novavax produced materials and quality review/approval of documentation related to produced materials.

This position reports directly to the Senior Director, Quality Operations (Internal).

Responsibilities include but are not limited to:

  • Quality leader to set and execute QA Operations goals and objectives with Novavax Development, Manufacturing, Quality Control, and Supply Chain to ensure Virus Stock, Cell Banks, and Drug Substance are developed, manufactured, tested, labeled, and shipped to meet domestic and international regulations including but not limited to FDA and EU GMPs. This includes interface with internal and external Qualified Persons (QPs), internal and external Novavax supply nodes and Contract Test Labs for manufacturing and testing of Novavax produced Virus Stock, Cell Bank and Drug Substance.
  • Supporting GMP/PAI Inspection Management and readiness activities as well as leading the Novavax Inc inspection readiness team.
  • Supporting global quality operational strategies by establishing critical quality and operational metrics and measurements and conducting trend analysis for Novavax Inc manufacturing and testing activities.
  • Provides mentorship, leadership, and prioritization to staff to execute their respective duties.
  • Builds and promotes a culture of Operational Excellence within QA.
  • Stays current and is an internal Novavax subject matter expert for changes in GXP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.
  • Effectively collaborates with departments across the company to analyze and resolve technical issues in accordance with appropriate quality standards.
  • Supports regulatory inspections as necessary, including authoring and review of regulatory submissions as it pertains to QA.

Minimum requirements:

  • Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 12+ years’ experience in the Pharmaceutical/Biotech industry with 5+ years management experience
  • Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, including technology transfer and PPQ.
  • Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and Eudralex Vol 4), including experience hosting regulatory inspections.
  • Excellent multi-tasking, analytical, organizational and leadership skills.
  • Ability to troubleshoot, identify root cause and systematically resolve problems.
  • Ability to communicate clearly and effectively with all levels of the organization.
  • Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.

Additionally, we prefer candidates that have:

  • The ability to effectively build and maintain relationships across the organization in order to effectively solve problems.
  • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
  • The ability to enable and drive change while being focused on internal and external customers.
  • Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax.
  • Capable to manage multiple priorities and maintain adherence to timelines.
  • Experience in validation (process, test methods, cleaning, equipment and utilities).

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.