Quality Assurance Specialist III, Supplier Quality and Compliance
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Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. 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.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
The Quality Assurance Specialist III– Supplier Quality & Compliance will be primarily responsible for supporting the implementation of GxP requirements to ensure compliance across the network.
This position reports directly to the Senior Director, Global Quality Systems and Compliance.
Responsibilities include but are not limited to:
- Evaluate and present solutions on complex issues with minimal input from senior staff.
- Review, track, and trend routine quality data.
- Perform quality review/assessment for new suppliers and service providers.
- Execute supplier complaint process with routine reports to management, assesses supplier’s qualification status and communicates potential risks.
- Prepare KPIs and understand how they add value in satisfying compliance questions.
- Support inspection readiness activities across the network.
- Support negotiations and ensure Quality Technical Agreements (QTAs) are in place with suppliers/vendors prior to use.
- Identify and support continuous improvement efforts across the quality organization.
- Maintain working knowledge of Novavax documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
- Effectively collaborate and communicate with departments across the company to analyze and resolve technical issues in accordance with appropriate quality standards.
- Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 8+ years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.
- 6+ years of experience in a Quality organization
- 3+ years industry experience in an auditing role
- Excellent understanding of Quality Assurance systems
- Strong knowledge foundation of FDA and EMA regulations regarding the manufacture of biologics and medical device/combo product (CFR 210, 211, and 820, 610).
- The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
- Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax.
- Capable of managing multiple priorities, adapt and maintain adherence to timelines.
- Individual must be willing to travel domestically and internationally (15%), as needed.
- Prior experience must include 4 years of collaborative clinical research activity, supply chain, GxP audit support; writing and reviewing SOPs, protocols, and data; working with GCP, GVP, GLP, and GCLP regulations and regulatory bodies including the FDA, EMA, MHRA or other national health authorities; and, performing data analysis for trends and root-cause analysis of critical and major challenges to make decisions in terms of compliance.
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.
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)
Gaithersburg, Maryland, USA
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