At Novavax, a clinical-stage vaccine company, we are creating tomorrow's vaccines today! We seek to attract, develop, and retain talented people who share our passion for science, medicine, and human health. We foster an environment of teamwork and collaboration, built on a culture that values and appreciates its employees. We are a fast-paced company that provides employees with opportunities to achieve personal and professional goals while also maintaining a balance between work and personal life.
We are seeking a QA Compliance Specialist III to join our Quality Assurance Development and Compliance Department. The qualified individual should have experience with US and international GMP regulations, guidance documents, industry best practice in all areas of a GMP environment.
Responsibilities include but are not limited to:
- Participates in oversight of Internal Audit and Supplier Quality Programs with guidance from management
- Leads internal and external audits of the various quality elements to ensure compliance to regulatory commitments and requirements, industry best practices and guidances
- Evaluates and presents solutions on complex issues (i.e. major deviations) with minimal input from senior staff
- Reviews, tracks and trends routine quality data. Reports adverse trends to management with remediation plan.
- Performs quality review/assessment for new suppliers and service providers
- Executes supplier complaint process with routine reports to management, assesses supplier's qualification status and communicates potential risks
- Independently writes and implements controlled documents (i.e., SOPs, Policies, Protocols) which may entail significant system changes
- Stays current with changes to current Good Manufacturing Practices, including FDA, EU, and other regulatory bodies (relevant to NVAX activities) and guidance bodies including ICH, ISPE, etc. so that NVAX's compliance policies are current and effective.
- Bachelor's degree in biological science is preferred.
- 6+ years' experience in GMP pharmaceuticals, biologics and/or vaccine manufacturing.
- 3+ years industry experience in an auditing role
- Knowledgeable in principles and current Good Manufacturing Practices (GMPs) in a development to commercial application setting.
- Strong knowledge foundation of FDA regulations regarding the manufacture of biologics (210, 211, and 610 CFR).
- Excellent multi-tasking, analytical, organizational and teamwork 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.
- Individual must be willing to travel domestically and internationally (15%), as needed.
Additionally, we prefer candidates that have:
- The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
- The ability to organize, prioritize and deliver tasks & projects according to pre-defined deliverables.
- The ability to enable and drive change while being focused on internal customers.
- Excellent communication skills both verbally and written; and across functions internally and externally to Novavax.
- Capable of managing multiple priorities.
- Produces high-quality work on complex problems with cross-functional involvement. Anticipates and proactively prevents risks and compromises to quality
Novavax, Inc. is a clinical-stage biotechnology company committed to delivering novel products to prevent a broad range of infectious diseases. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats. Our vaccine candidates are genetically engineered three-dimensional nanostructures that incorporate recombinant proteins critical to disease pathogenesis.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Rockville, Maryland and Uppsala, Sweden. Novavax is traded on the Nasdaq Stock Market under the symbol NVAX and is dedicated to developing novel vaccines to address infectious disease.
Novavax, Inc. offers a base salary, annual bonus, stock options, 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, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.