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Vice President, Quality Operations and CDMO Quality

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 a VP, Quality Operations and CDMO Quality to reformat the current Quality Operations functional area into a global and commercially viable Corporate group. This is a new position that we are seeking to ensure final drug product is comparable across all global sites (internal and CDMO) from a QA and cGMP compliance perspective. This strategic leader will develop the group to accomplish this objective. This position is also responsible for final drug product release globally.

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:

Define, implement and execute global strategy with multiple US and ex-US CDMO partners and Novavax sites to ensure product is consistently developed, manufactured, tested, labeled, released, and shipped to meet domestic and international regulations including FDA and EU GxP requirements. This includes interface with Qualified Persons (QPs) at all applicable sites and regions.

Responsible for global product releases, including drug product.

Develop global quality operational strategies by establishing critical quality and operational metrics and measurements; conducting trend analysis; system design and implementation.

Provides mentorship, leadership, and prioritization to staff to execute their respective duties.

Builds and promotes a culture of Operational Excellence within QA.

Stays current and is an internal Novavax subject matter expert for changes in GxP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.e.: ICH, PTC, ISPE, etc.), and best industry practices.

Effectively cooperates with departments across the company and partner sites (CDMO and NVAX) to analyze and resolve technical issues in accordance appropriate quality standards.

B.S. in scientific discipline

15+ years Quality Assurance experience in pharmaceutical, biologics and/or vaccine manufacturing

Minimum of 7 years supervisory experience

Knowledge and experience in principles and practice of current Good Manufacturing Practices (cGMPs) , Good Distribution Practices, and Good Laboratory Practices (GLPs) for FDA and EU expectations

Experience with analytical methods, method qualification, validation and transfer

Demonstrated verbal and written skills in communicating regulatory and technical information

Strong command of the English language and demonstrated editing skills

Flexible and adaptable to changing priorities. Ability to work under pressure within tight time frames

Strong interpersonal skills and sense of business ethics

Excellent time management and organizational skills and attention to detail

A d d iti ona ll y , w e pr e f er can d i da t es t h a t ha v e:

Experience in project management

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 , Vice President, Quality Operations and CDMO Quality, Other , Gaithersburg, DC

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