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Novavax Vice President, Quality Operations and CDMO Quality in Darnestown, Maryland

less thantable border="0" cellpadding="3" cellspacing="0">less thantbody>less thantr>less thantd align="right" valign="top">less than/td>less thantd>less than/td>less than/tr>less than/tbody>less than/table>less thanp>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.Novavaxis undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. 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.Novavaxis 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.less than/p>less thanp>We are seeking a less thanstrong>VP, Quality Operations and CDMO Qualityless than/strong> to reformat the current Quality Operations functional area into a global and commercially viable Corporate group. This is a new position that we are seeking to ensure final drug product is comparable across all global sites (internal and CDMO) from a QA and cGMP compliance perspective. This strategic leader will develop the group to accomplish this objective. This position is also responsible for final drug product release globally.less than/p>less thanp>less thanstrong>less thanu>Rless than/u>less than/strong>less thanstrong>less thanu>esponsibilities include but are not limited to:less than/u>less than/strong>less than/p>less thanul>less thanli>Define, implement and execute global strategy with multiple US and ex-US CDMO partners and Novavax sites to ensure product is consistently developed, manufactured, tested, labeled, released, and shipped to meet domestic and international regulations including FDA and EU GxP requirements. This includes interface with Qualified Persons (QPs) at all applicable sites and regions.less than/li>less thanli>Responsible for global product releases, including drug product.less than/li>less than/ul>less thanul>less thanli>Develop global quality operational strategies by establishing critical quality and operational metrics and measurements; conducting trend analysis; system design and implementation.less than/li>less than/ul>less thanul>less thanli>Provides mentorship, leadership, and prioritization to staff to execute their respective duties.less than/li>less than/ul>less thanul>less thanli>Builds and promotes a culture of Operational Excellence within QA.less than/li>less thanli>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.less than/li>less than/ul>less thanul>less thanli>Effectively cooperates with departments across the company and partner sites (CDMO and NVAX) to analyze and resolve technical issues in accordance appropriate quality standards.less than/li>less than/ul>less thanp>less thanstrong>less thanu>Miless than/u>less than/strong>less thanstrong>less thanu>nless than/u>less than/strong>less thanstrong>less thanu>imless than/u>less than/strong>less thanstrong>less thanu>uless than/u>less than/strong>less thanstrong>less thanu>m Requirements:less than/u>less than/strong>less than/p>less thanul>less thanli>B.S. in scientific disciplineless than/li>less thanli>15+ years Q