Senior Director, Data Integrity & Quality Risk Management

Company: Novavax
Location: Gaithersburg
Posted on: May 27, 2023

Job Description:

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. Novavaxis 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.Novavaxis a leading innovator of recombinant vaccines. Our proprietary technology platform leverages the 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. Summary of the Position : We are developing our global data integrity and risk management capabilities in support of our promising SARS-COV-2 and NanoFlu Vaccine programs. We have a Senior Director position that we are seeking to fill with a candidate that is ready to contribute to these growing team and important programs. The successful candidate will be a member of the Quality Assurance Team reporting into the Vice President, Global Technical Quality; working collaboratively with internal and external teammates in all departments to develop and oversee the Data Integrity and Quality Risk Management programs. Responsibilities include but are not limited to : Senior global quality leader to set and execute global Data Integrity and Quality Risk Management strategy with input from relevant business partners and management. This will include developing strategy documents (policies and guidance) as well as writing detailed processes and procedures. Directs the strategy for design, deployment and continuous improvement of the global and local Novavax Quality Risk Management Program including the company's risk register. Directs the strategy for design, deployment and continuous improvement of the global and local Novavax Data Integrity & Quality Risk Management Programs. Participate with both internal and external audits to ensure compliance with current regulations. Work closely with training groups to assist in the continual development of and use of relevant tools for both Data Integrity and Risk Management. Directing staff (either internal or contract) during the execution of IQ/OQ/PQ protocols. Initiation and approval of change controls to determine impact of changes to facility, utilities, equipment, process/product as applicable, and system owners. Investigation and approval of exceptional conditions during the execution of protocols as well as other atypical events, deviations, and non-conformances as required. Provides mentorship, leadership, and prioritization to staff to execute their respective duties. Builds and promotes a culture of Operational Excellence within the Quality Unit. Supports regulatory inspections as necessary. Minimum Requirements : Bachelor's degree in biological science or other science. 15+ years' experience in GMP pharmaceutical, biologics and/or vaccine manufacturing. 10+ years' supervisory experience. 10+ years' applicable experience in the areas of Data Integrity & Quality Risk Management. In depth knowledge of regulations for Data Integrity and Risk Management, including FDA, EMA, PICs, and WHO. Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application. Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and Eudralex Vol 4), including regulatory inspection or support experience is preferred. Excellent multi-tasking, analytical, organizational and leadership skills. The flexibility to strategize a new direction of his/her work when change is encountered or necessary; to help teammates with their own agility in a changing context. Ability to troubleshoot, identify root cause and systematically resolve problems. The ability to represent the team cross-functionally; to apply an understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas. The capability to recognize inefficiencies in the team and identifies improvements constructively; to work across teams effectively and frequently collaborate on larger items involving other areas. To contribute significantly to cross-functional work; to network with senior internal and external peers in own area of expertise and demonstrates leadership and ownership of issues. Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs. The ability to effectively build and maintain relationships with 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. Capable to manage multiple priorities and maintain adherence to timelines. 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. 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. 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)

Keywords: Novavax, Washington DC , Senior Director, Data Integrity & Quality Risk Management, Executive , Gaithersburg, DC