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 Quality Systems Compliance Manager to join our Quality Assurance Department. The Manager will be responsible for leading and developing the Supplier Quality (including Supplier Audit) and Internal Audit programs within the Quality Systems Department. The position will be located at our Gaithersburg, MD facility and will report to the Associate Director, Quality Systems.
Responsibilities include but are not limited to:
- Design, deployment and continuous improvement of the Internal Audit Program
- Design, deployment and continuous improvement of the Supplier Quality Program
- Management and maintenance of Quality Systems that will ensure there are appropriate cGMP programs utilized for the manufacture of Novavax Drug Substance and Drug Product (for internal and external manufacturing)
- Create, track and assist in presenting metrics related to the Supplier Quality and Internal Audit Programs for Senior Management
- Participate in regulatory inspections and maintain a state of inspection readiness
- Maintain working knowledge of Novavax Documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance
- Management of staff
- Other duties as assigned
- Bachelor's degree in a scientific discipline
- 12+ years of Quality experience in pharmaceutical, biologics and/or vaccine manufacturing
- Minimum of 2 years supervisory experience
- Knowledge and expertise in principles and practices of current Good Manufacturing Practices (cGMP)
- Demonstrated verbal and written skills in communicating regulatory and technical information
- Solid organizational and time management skills, proven project management, presentation and facilitation skills
- Biotechnology experience preferred
- Innovation including looking internally and externally for best practices
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 with a sense of urgency under minimal supervision without neglecting attention to detail
- The ability to enable and drive change while being focused on internal and external customers
- The ability to communicate well both verbally and in writing with all levels both inside and outside of the organization
- Prior experience with electronic Quality Management solutions (deployment and maintenance)
- Capable to manage multiple priorities
- This position may require periodic weekend/evening work
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.