(Contract) Associate Director, Quality Logistics
Company: Moderna Therapeutics
Location: Somerville
Posted on: June 16, 2022
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Job Description:
The Role:Reporting to the Director of Quality Logistics within
Moderna's Research & Development Quality (RDQ) organization,
located at the Moderna Headquarters in Cambridge, MA, the Associate
Director of RDQ Quality Logistics, will contribute to growing and
shaping Moderna's R&D Quality function focusing on a training
and competencies program for RDQ staff. - The Associate Director,
Quality Logistics will be responsible for development, execution
and maintenance of a comprehensive R&D GxP cross-functional
training and competencies program for - RDQ staff. - The Associate
Director, Quality Logistics will contribute to creating a quality
culture within Moderna and drive toward a sustained state of
inspection readiness.Here's What You'll Do:Assist the Director,
Quality Logistics in development of the RDQ Annual Audit Plan and
periodic review, updates and maintenance of the PlanAssist the
Director, Quality Logistics in liaising with other RDQ functions to
build the RDQ Audit Schedule and ensure audits are resourced
appropriatelyBuild, execute and maintain a RDQ cross-functional
training program and skills matrix designed to monitor and track
RDQ staff competencies and development of cross-functional GxP
capabilitiesContribute to the development of quality and compliance
strategies across the RDQ organizationProvide input, as applicable
to development of RDQ and R&D policies and
proceduresParticipate in regulatory authority inspections, as
necessary, and provide input and review of responses to inspection
observations and regulatory agency questions resulting from these
inspectionsActively participate in implementing new strategies,
innovation and solutions to the RDQ programContribute to the
continuing development of a quality culture at Moderna.Here's What
You'll Bring to the Table:BS/BA with a minimum of 8 to 10 years'
experience or MS with 5 to 8 years' experience in pharmaceutical /
biotech / vaccines industryStrong knowledge of relevant FDA, EU,
ICH GCP guidelines, regulations.Ability to build, execute and
maintain a training matrix and curriculum for GCP, GVP, GLP and
GcLP quality staff that includes a program for assessing staff
competencies.Knowledge / experience developing annual audit plans
and managing a consolidated audit schedule for all GCP, GVP, GLP,
GcLP and CSV audit types is desired.Strong interpersonal skills and
ability to interact effectively with all levels within the
organization.Experience in supporting regulatory authority
inspections and developing responses to regulatory authority
inspection findings is a plus.Ability to solve complex problems
taking a broad perspective to identify innovative solutions.Ability
to manage multiple projects in a fast-paced environment. -Ability
to collaborate effectively in a dynamic, cross-functional matrix
environment.Knowledge working with digital systems in the audit
environment is a plus.Candidates should be aware that Moderna
currently maintains a policy requiring all US-based employees to be
fully vaccinated against COVID-19and receive a booster shot once
eligible. Newly hired employees must be vaccinated and boosted
prior to their employment start date. Moderna is an equal
opportunity employer and will provide a reasonable accommodation to
those unable to be vaccinated or receive a booster where it is not
an undue hardship to the company to do so as provided under
federal, state, and local law.About ModernaIn over 10 years since
its inception, Moderna has transformed from a research-stage
company advancing programs in the field of messenger RNA (mRNA), to
an enterprise with a diverse clinical portfolio of vaccines and
therapeutics across seven modalities, a broad intellectual property
portfolio in areas including mRNA and lipid nanoparticle
formulation, and an integrated manufacturing plant that allows for
rapid clinical and commercial production at scale. Moderna
maintains alliances with a broad range of domestic and overseas
government and commercial collaborators, which has allowed for the
pursuit of both groundbreaking science and rapid scaling of
manufacturing. Most recently, Moderna's capabilities have come
together to allow the authorized use and approval of one of the
earliest and most effective vaccines against the COVID-19
pandemic.Moderna's mRNA platform builds on continuous advances in
basic and applied mRNA science, delivery technology and
manufacturing, and has allowed the development of therapeutics and
vaccines for infectious diseases, immuno-oncology, rare diseases,
cardiovascular diseases and autoimmune diseases. Moderna has been
named a top biopharmaceutical employer by Science for the past
seven years. To learn more, visit .Moderna is a smoke-free,
alcohol-free and drug-free work environment.Moderna is committed to
equal employment opportunity and non-discrimination for all
employees and qualified applicants without regard to a person's
race, color, gender, age, religion, national origin, ancestry,
disability, veteran status, genetic information, sexual orientation
or any characteristic protected under applicable law. Moderna will
make reasonable accommodations for qualified individuals with known
disabilities, in accordance with applicable
law.#LI-ED1-SummaryLocation: Cambridge, Massachusetts; QualityType:
Full time
Keywords: Moderna Therapeutics, Somerville , (Contract) Associate Director, Quality Logistics, Executive , Somerville, Massachusetts
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