Senior Director, Supplier Quality & Compliance

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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.

Summary of the Position:

We are seeking a Senior Director, Supplier Quality and Compliance to join our Global Quality Systems and Compliance department in Gaithersburg, MD. The Senior Director, Supplier Quality and Compliance will oversee and manage the global supplier quality and compliance functions.  The candidate will be responsible for developing and leading a best-in-class supplier quality system that will support both clinical and commercial manufacturing operations.  The candidate will also be responsible for managing the overall quality and compliance system for the Novavax network, which includes establishing compliance procedures and developing organizational strategies to ensure the company complies with regulatory requirements of various geographies.

This position reports directly to the Vice President, Global Quality Systems and Compliance.

Responsibilities include but are not limited to:

  • Serve as a technical authority in drug regulations and industry standards to ensure consistency in interpretation of cGMPs throughout the network.
  • Provide oversight and guidance on identifying compliance gaps and recommend and implement remediation efforts.
  • Identify strategic initiatives to drive continuous improvement opportunities within the supplier quality and compliance functions.
  • Identify and coordinate resources and effectively communicate process, outcomes, and timelines.
  • Establish and maintain corporate audit structure.
  • Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GMP, GCP and GVP QA activities.
  • Manages corporate inspection readiness activities and delivers training, as applicable.

Minimum requirements:

  • Bachelor’s degree in a scientific discipline; Master’s degree or higher preferred
  • 15+ years' experience in GMP pharmaceutical, biologics and/or vaccine manufacturing
  • 10+ years of leadership experience in Quality Assurance.
  • Extensive knowledge of U.S., EU, and ICH regulations and guidance’s related to GxP activities.
  • Proven leadership skills preferred for cross-functional global team environment.
  • Strong ability to interact with internal and external stakeholders to shape and direct strategy in his/her areas of responsibility.
  • Experience in working with external partners to drive and influence quality expectations and deliverables.
  • Excellent analytical skills and ability to communicate complex issues in a simple way and to organize plans to resolve issues and mitigate risk.
  • Strong conflict management and negotiation skills.
  • Strong, collaborative team player that has a customer service approach and is solution oriented.

Preferred requirements:

  • 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.

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.

#LI-KC #LI-remote 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Job details
Quality Assurance
Remote - US
Gaithersburg, Maryland, USA
Novavax HQ
Gaithersburg, Maryland, USA
SENIO004007
Full-time
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