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
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
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
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
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
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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