Novavax
  • 17-May-2021 to 16-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 leveragesthe 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 Vice President Clinical Quality Assurance to join our Clinical Quality Assurance department in Gaithersburg, MD. The Vice President, Clinical Quality Assurance will provide leadership and collaborate with required functional areas to ensure compliance with applicable GCP, GVP and GCLP regulations as well as any additional applicable regulatory requirements. The VP is expected to build and maintain cross-functional relationships with key functional areas including but not limited to: Clinical Operations, Pharmacovigilance, and Regulatory Affairs.

This position reports to the Senior Vice President, Chief Regulatory and Quality Officer.

Responsibilities include but are not limited to:

  • Serves as the strategic leader and operational manager to direct, oversee, and manage all clinical quality assurance activities.
  • Drives the design, analysis, and oversight of global, phase-appropriate clinical Quality Management System (QMS) policies and procedures to ensure compliance to applicable regulations, including U.S. and EU.
  • Directs, oversees, and manages the quality oversight of GCP, GVP and GCLP activities (including SOP/policy development and maintenance, Vendor Management, internal and external audit functions, and clinical batch release program) to ensure patient safety and data integrity.
  • Provide leadership, direction, and mentorship across all levels of the organization to assure quality assurance strategies are known and implemented.
  • Keep senior leadership apprised of changes to the clinical quality compliance landscape affecting business performance.
  • Develop and administer budgets, plans, and performance requirements linked to the clinical quality assurance department.
  • Hire, develop, and retain clinical QA personnel (including contract staff) to create a high-performing credible team.
  • Serve as the primary contact in QA for the oversight of Clinical Studies in US, EU, and ROW to ensure compliance with all GCP's from manufacturing, labeling, distribution, and site qualification to ensure compliance with all Regulatory requirements in the country the study is conducted.
  • Liaise with the Head of Clinical, Medical Affairs, Regulatory Affairs, Pharmacovigilance, and Information Technology as needed for the Clinical studies.
  • Establish/ensure/remediate as needed the current quality processes, systems and procedures associated with clinical studies.
  • Collaborate with cross-functional management to drive clinical process improvements and alignments.
  • Serve as the primary contact for all Regulatory or Third-Party inspections related to Novavax sponsored Clinical and Pharmacovigilance activities. This includes on site at Novavax and remote sites.
  • Maintain in depth understanding of business principles, industry dynamics, regulatory environment, market trends, and specific operational details related to GCP and GVP QA activities.

Minimum Requirements:

  • BS with 15+ years' experience in the Pharmaceutical/Biotech industry with 10+ years leadership experience.
  • 10+ years' experience in GCP/GVP QA.
  • Experience with senior level interactions and influence with Clinical, Regulatory, Pharmacovigilance and Medical Affairs functions.
  • Excellent communication and organizational skills.
  • Excellent understanding of GCP, GCLP and GVP expectations.
  • Knowledge of global regulatory expectations (including FDA and EMA).

Preferred Requirements:

  • Strong understanding of GCP, GLP, and PV Quality for pre-clinical and clinical stage work.
  • Direct experience in successfully managing Health Authority Inspections and multiple projects and responsibilities concurrently.
  • Experienced and fully capable to implement and ensure quality in a GCP-regulated environment (eg, GCP oversight, auditing, electronic systems management, laboratory management, PAI inspection readiness)
  • Skilled in developing collaborative internal and external relationships.
  • Team player willing to roll up her/his sleeves as the situation requires to get the right result; ability to combine hands-on attention to detail with the ability to step back and think strategically.
  • Ability to make rationale, scientific, timely, and compliant risk-based decisions.
  • Excellent verbal and written communication skills
  • Ability to build and manage a high performing group; attract, retain, and coach best talent. Develops direct reports in their career paths, particularly ensuring that a successor is evolved.
  • Ability to think creatively, take a broad systemic view while maintaining a meticulous eye for detail round out the description of the intellectual skills required for this position.

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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