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Associate Director, Quality Assurance Training

Company: Novavax
Location: Gaithersburg
Posted on: September 17, 2020

Job Description:

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 is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. 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.

We are seeking an Associate Director, QA Training to join our Quality Assurance Department.

This position reports directly to the Vice President, Quality Systems and Compliance

R espons i b i l i t i es i n c l u d e but are n o t l i m it ed t o:

Design, deployment and continuous improvement of Novavax GxP Training Program

Create, track and present metrics related to the Training Program to 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

Lead the identification, acquisition and use of learning technology including a Learning Management System

Partner with internal stakeholders and serve as the technical resource for training and instructional design

Develop and assess instructional effectiveness processes

Work within project teams to design training strategy for system implementation

Management of staff

Bachelor's degree in a scientific discipline

10+ years of Quality experience in pharmaceutical, biologics and/or vaccine manufacturing

Minimum of 5 years supervisory experience

Knowledge and expertise in principles and practices of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP)

Demonstrated verbal and written skills in communicating regulatory and technical information

Solid organizational and time management skills, proven project management, presentation and facilitation skills.

Preferred: Biotechnology experience preferred.

Innovation including looking internally and externally for best practices

Preferred Requirements :

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 Learning and Documentation Management systems (deployment and maintenance)

Capable to manage multiple priorities

Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in 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.

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Keywords: Novavax, Washington DC , Associate Director, Quality Assurance Training, Other , Gaithersburg, DC

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