Quality Assurance Specialist IV, Quality Operations (Contract)

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Novavax, Inc. (Nasdaq:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

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.

We are seeking a Distribution Quality Specialist IV to join our Quality Ops Materials department in Gaithersburg, MD. This position is responsible for routine Quality oversight of Supply Chain and Distribution and associated materials management activities. The position is responsible for ensuring the warehouse and area personnel activities remain in compliance with CFR, FDA and ICH Guidances, global regulatory expectations, and international cGMPs. Responsibilities include providing quality oversight for area specific change controls, deviations and CAPAs and participating in and reviewing investigations. The position will provide quality oversight for Materials Management including transportation, receiving, materials storage and materials management operations at the
internal and external manufacturing warehouse.

This position reports directly to the Quality Assurance Director.

Responsibilities include but are not limited to:
• Create and/or approve SOPs, temperature deviation investigations, and change controls as part of GMP quality compliance. Contribute to contract reviews such
as Quality or Supply Agreements
• Quality oversight for domestic and international shipments through delivery, including transactions for reconciliation in SAP.
• Ensure shipping and handling and storage are in line with quality requirements.
• Provide oversight for Materials Management, and Supply Chain activities such that they always remain GMP compliant.
• Provide Quality oversight of day-to-day shipping, receiving, materials storage and issuance, and other Materials Management and Supply Chain activities.
• Provide guidance and support in responding to deviations associated with warehouse and materials management operations. Confirm thorough and
effective CAPAs are implemented as necessary.
• Ensure that change controls for the area adhere to requirements and provide area impact assessments for change controls.
• Responsible for quality oversight of shipping requirements, temperature excursions
• Communicate with Distribution/Supply Chain management for Quality related issues.
• Notify Quality Management of any quality issue that may be regulatory significant or impact the acceptability of product or materials.
• Contribute to weekly distribution team meetings.
• Write deviations and provide support of CAPAs and Change Controls as it pertains to the disposition of Materials and Material Specifications
• Support Quality Operations as required including review of deviations and support of CAPAs and Change Controls as it pertains to manufacturing and
materials management operations.

Minimum Requirements:
• Bachelor’s degree in biology, Chemistry, Engineering, BS with 5+ years’
experience in the Pharmaceutical/Biotech industry
• Strong knowledge foundation of FDA and EU regulations regarding the
manufacturing of biologics (210, 211, and 610 CFR and Eudralex Vol 4)
• Understanding of Quality Assurance systems
• Strong communication and organizational skills
Preferred Requirements:
• Demonstrated ability to manage multiple priorities and maintain adherence to
• Demonstrated ability to manage process improvement projects
• Demonstrated ability to identify and implement cross-functional improvements
• Demonstrated ability to maintain relationships across the organization
• Demonstrated knowledge of quality systems
• Demonstrated ability to lead complex investigations with minimal supervision

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.

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
Novavax HQ
Gaithersburg, Maryland, USA
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