Director/Senior Director, Clinical Quality Assurance Systems and 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 late-stage biotechnology company that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases. Novavax is uniquely qualified to address the enduring need for innovative vaccines. We utilize our proprietary recombinant technology platform, which combines genetic engineering's power and speed to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. We have more than a decade of experience contending with some of the world's most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.

    We are seeking a Director/Senior Director, Clinical QA Systems and Compliance to join our Clinical Quality Assurance department in Gaithersburg, MD. The Director/Senior Director, Clinical QA Systems and Compliance will be primarily responsible for developing, improving and maintaining Phase Appropriate Quality processes and procedures supporting Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) activities. The incumbent will also liaise with Clinical Operations, Pharmacovigilance, Medical Affairs, IT and Regulatory, as needed.

    This position reports to the Senior Director, Clinical Quality Assurance.

    Responsibilities include but are not limited to:

    • 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, a 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
    • Establish and maintain phase appropriate Quality Systems to support clinical studies, including pharmacovigilance activities
    • Oversee significant quality issue management process to ensure effective CAPAs and drive impact assessments for existing process and procedures
    • 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
    • Manages Inspection Readiness activities and delivers training for individual/small group/large group training

    Minimum Requirements:

    • BS with 12+ years' experience in the Pharmaceutical/Biotech industry with 5+ years supervisory experience
    • 10+ years' experience in GCP/GVP QA
    • Experience with senior level interactions and influence with Clinical, Regulatory 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:

    • Established recognition as a technical expert
    • Demonstrated success leading multiple teams
    • The ability to represent QA cross-functionally and globally; to apply understanding of the team's place in the larger organization, and discuss changes, progress, and issues as they relate to other areas

    This position may require periodic weekend/evening work and approximately 15% domestic and international travel.

    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: 610800816Posted: 2021-03-21Job Title: Senior Director Clinical