Senior Director, Product Quality Compliance

    Updated 30+ days ago
    Gaithersburg, MD 20877
    Full-time, Part-time
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    Job Description

    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.

    We are seeking a Senior Director, Product Quality Compliance to join our Quality Assurance department in Gaithersburg, MD. The Senior Director, Product Quality Compliance will serve as the strategic leader and operational manager to direct, oversee, and manage Quality Engineering and Product Quality Complaint activities. Quality Engineering activities include coordination of change management execution, nonconformance/OOS/issue management execution, Quality support to technical teams. Product Quality Complaint activities include ownership and oversight of the Global Product Quality Complaint handling process.

    This position reports directly to the Vice President, Quality Operations.

    Responsibilities include but are not limited to:

    • Senior quality leader to set and execute QA Product Quality Compliance strategy and processes in collaboration with Development, Manufacturing, Quality Control, Supply Chain, and Pharmacovigilance/Product Safety to ensure product compliance with domestic and international regulations including FDA and EU GxPs and approved product dossiers.
    • Supports and/or hosts internal and external audits of Product Quality Compliance systems/processes.
    • Provides mentorship, leadership, and prioritization to staff to execute their respective duties.
    • Builds and promotes a culture of Operational Excellence within QA.
    • 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.
    • Effectively collaborates with departments across the company to analyze and resolve technical issues in accordance with appropriate quality standards.

    Minimum requirements:

    • Bachelor's Degree in Biology, Chemistry, Engineering, or related field.
    • 15+ years' experience in GMP pharmaceutical, biologics and/or vaccine manufacturing.
    • 10+ years' supervisory experience.
    • Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development through commercial application, including technology transfer and PPQ.
    • Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and Eudralex Vol 4), including experience hosting regulatory inspections.
    • Excellent multi-tasking, analytical, organizational and leadership skills.
    • Ability to troubleshoot, identify root cause and systematically resolve problems.
    • Ability to communicate clearly and effectively with all levels of the organization.
    • Proficient in Window based software to include Excel, Word, and Access.
    • Ability to adapt to changing software programs.

    Additional preferred requirements:

    • The ability to effectively build and maintain relationships across the organization 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 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.

    Job Posted by ApplicantPro
    Posting ID: 610501453Posted: 2021-03-21Job Title: Senior Director Product Quality