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Quality Assurance Compliance Specialist III
Novavax Gaithersburg, MD
$96k-115k (estimate)
Full Time | Pharmaceutical 3 Months Ago
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Novavax is Hiring a Quality Assurance Compliance Specialist III Near Gaithersburg, MD

TITLE: Quality Assurance Compliance Specialist III (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 III will be responsible for supporting the supplier quality programs as well as serving as lead corporate and supplier audits.

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:

  • Serve as lead corporate and supplier auditor and Supplier Quality Programs minimal guidance from management.
  • 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.
  • Independently author and revise controlled documents (e.g.., SOPs, Policies, Protocols, Work Instructions).
  • 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.
  • Serve as subject matter expert for supplier management during audits and regulatory inspections.
  • 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.
  • Provides oversight and guidance to junior level specialists.

Minimum Requirements:

  • 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 quality systems 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.
  • Ability to troubleshoot, identify root cause and systematically resolve problems.
  • Ability to communicate clearly and effectively with all levels of the organization.
  • PC literacy required; MSOffice skills (Outlook, Excel, Word, SharePoint and PowerPoint). Ability to adapt to changing software programs.
  • Individual must be willing to travel domestically and internationally (15%), as needed.

Preferred Requirements:

  • Demonstrated ability to produce high-quality work on complex problems with cross-functional involvement.
  • Anticipates and proactively prevents risks and compromises to quality.
  • Demonstrated advanced technical knowledge.
  • Demonstrated ability to lead and develop more junior employees.
  • Demonstrated ability to manage process improvement projects.
  • Demonstrated ability to recognize inefficiencies in the team and identifies improvements constructively.
  • Demonstrated knowledge of quality systems regulatory requirements for medical device or combo products
  • 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
  • Ability to contribute significantly to cross-functional work. Networks with internal and external peers in own area of expertise.
  • The ability to keep colleagues and management apprised of projects and status independently and appropriately; to anticipate future needs based on prior experiences.
  • Accountability to reach established goals or targets for moderately complex tasks with the involvement of immediate teammates without compromising commitments.
  • 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.

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 Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$96k-115k (estimate)

POST DATE

12/18/2022

EXPIRATION DATE

08/22/2023

WEBSITE

novavax.com

HEADQUARTERS

GAITHERSBURG, MD

SIZE

500 - 1,000

FOUNDED

1987

TYPE

Public

CEO

STANLEY C ERCK

REVENUE

$200M - $500M

INDUSTRY

Pharmaceutical

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About Novavax

Novavax is a biotechnology company that develops and commercializes vaccines for the treatment of infectious diseases.

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