Quality Assurance Specialist Iv, Supplier Quality And Compliance

TITLE: Quality Assurance Compliance Specialist IV (Supplier Quality & Compliance)

LOCATION: Gaithersburg, MD

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. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, and achieved positive Phase 1 clinical trial results. 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. Novavax is 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.

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.

Summary of the Position:

We are seeking a Quality Assurance Compliance Specialist IV (Supplier Quality & Compliance) to join our Quality department in Gaithersburg, MD. The Specialist IV will be responsible for supporting quality systems across the GMP organization including Deviation, CAPA and Change Control systems. The Specialist is expected to work cross-functionally to support robust quality record content and timely completion, and facilitation of documentation of all records within the EQMS (electronic quality management system).

This position reports directly to the Senior Manager, Supplier Quality & Compliance and requires a minimum of 3 days on-site per week.

Responsibilities include but are not limited to:

• 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 internally and externally to analyze and resolve complex technical issues in accordance with appropriate quality standards, with minimal input from senior management. Review, track, and trend routine supplier quality data.
• Independently author and revise controlled documents (e.g.., SOPs, Policies, Protocols, Work Instructions).
• Serve as subject matter expert for supplier management during audits and regulatory inspections.
• Support negotiation and ensure Quality Technical Agreements (QTAs) are in place with CMOs/Suppliers in preparation for technical transfer or contract manufacturing, contract packaging/labeling for clinical and commercial products.
• Monitor the performance of suppliers while identifying potential issues to improve quality and efficiently
• Serve as lead corporate and supplier auditor across the Novavax network
• Manage the day-to-day activities and operations of the Corporate Audit and Supplier Quality Programs.
• Execute supplier complaint process with routine reports to management, assess supplier’s qualification status and communicate potential risks.
• Provides oversight and guidance to junior level specialists.
• Perform quality review/assessment for potential new suppliers and service providers.

Minimum Requirements:

• Bachelor’s Degree in Biology, Chemistry, Engineering, or related field with 10+ years’ experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.
• 8+ years of quality systems experience in a Quality organization

• 5+ 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).

• Capable of managing multiple priorities, adapt and maintain adherence to timelines.
• Individual must be willing to travel domestically and internationally (15%), as needed.
• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
• PC literacy required; MSOffice skills (Outlook, Excel, Word, SharePoint and PowerPoint). Ability to adapt to changing software programs.
• Excellent communication skills both verbally and written; and with various organizational levels internally and externally to Novavax.
• Ability to communicate clearly and effectively with all levels of the organization.
• Ability to troubleshoot, identify root cause and systematically resolve problems.

Preferred Requirements:

• Anticipates and proactively prevents risks and compromises to quality.
• Demonstrated ability to produce high-quality work on complex problems with cross-functional involvement.

• Ability to apply understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
• Demonstrated ability to lead and develop more junior employees.
• The ability to keep colleagues and management apprised of projects and status independently and appropriately; to anticipate future needs based on prior experiences.
• Demonstrated knowledge of quality systems regulatory requirements for medical device or combo products
• The capability to build influence by completing tasks and presenting new ideas; to contribute to cross-functional work; to build relationships internally and coordinates work with others.
• Ability to contribute significantly to cross-functional work. Networks with internal and external peers in own area of expertise.
• Demonstrated advanced technical knowledge.
• Demonstrated ability to recognize inefficiencies in the team and identifies improvements constructively.
• Demonstrated ability to manage process improvement projects.
• Accountability to reach established goals or targets for moderately complex tasks with the involvement of immediate teammates without compromising commitments.

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)