Vice President, QA/RA/Clinical (Redwood City)
Company: Talis Biomedical
Location: Redwood City
Posted on: May 6, 2022
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Job Description:
About the CompanyOur purpose at Talis is to advance health
equity and outcomes by delivering accurate infectious disease
testing in the moment of need, at the point of care.While timely
diagnosis of infectious diseases is critically important to enable
effective treatment, testing is primarily performed in centralized
laboratories, which require samples to be shipped for processing,
delaying the return of results by days. Point-of-care testing
solves this problem by delivering the timely information necessary
for clinical care.To deliver our purpose we focus on three things:*
Putting customers and patients first* Making Talis a great place to
work* Living our values to Dream Big, Share Our Screens, Serve
Others, Bring Our A Game, and Build TrustThe Opportunity* Vice
President, QA/RA/CA to provide high-level strategic leadership to
Talis's Regulatory Affairs (RA), Quality Assurance (QA), and
Clinical Affairs (CA) teams.* Work collaboratively and
cross-functionally with R&D, Manufacturing, Commercial, and
Marketing executives to provide clinical and regulatory expertise
to complete project deliverables, often under stringent timelines.*
Develop and lead an engaged team that is innovative, agile,
receptive of change, and willing to constantly learn in a rapid
growing environment.* Expert regulatory and clinical development
leadership of all pre-clinical and post-market studies for IVD
medical device(s) including study design, clinical monitoring,
safety, risk, and feasibility assessments, site selection, clinical
compliance, and successful submission execution.* Be actively
involved in the development of clinical protocols, Investigator
Brochures, Clinical Study Reports, TMF, and other various critical
study documents.* Ensure operational oversight to clinical teams,
communicating trial objectives, timelines, budgets, and overseeing
proper resource allocation, data management, and statistical
analysis.* Ongoing development of Quality Management System (QMS),
including SOP creation, adhering to FDA and GxP requirements,
training, management, and oversight of audits & certifications.*
Support overall business strategy by maintaining robust regulatory
compliance, develop quality standards, establish vendor and
external KOL relationships, and ensure inspection-readiness at all
times.* SME for continuous QA/RA/CA improvement* Review and execute
on all relevant departmental policies, procedures, and trainings.*
Mentor, lead, and develop employees, focused on performance
management, living our values, and succession planning.Who You Are*
Bachelor s degree required in a science or engineering field. MS,
MBA, PhD preferred.* Extensive experience in the biotech/Medical
Device space, specifically with IVD. Knowledge of Software as a
Medical Device (SaMD) products is a benefit.* 15+ years combined
experience in Quality Assurance, Regulatory, and Clinical Affairs.*
Experience in smaller sized companies/start-up environments
necessary.* Developed strong relationships with regulatory
authorities.* 5+ years of direct management experience.* Able to
organize, prioritize and execute to achieve company goals.*
Proficiency with ISO 13485, MDSAP, IVDR and GxP requirements.*
Basic knowledge and familiarity with software terminology and
testing, validation, and user requirements, and IQ/OQ/PQ.*
Demonstrated success spearheading medical device products through
FDA, Health Canada, and the EU as well as ROW.* Extensive
experience hosting regulatory audits/inspections as the primary
point of contact.* Expert level project management skills to build
and execute on RA/QA/CA plans.* Cross functional leadership skills
for interaction with internal executive team members, as well as
with external Board of Directors, investors, and other 3 rd
parties.Talis offers a comprehensive health and well-being benefits
programs, long-term equity incentives, time-off policies, a 401(k)
retirement savings plan with an immediate Company match, Education
Assistance Program, a rotating suite of snacks, Monday breakfasts,
Happy Hours, other fun company events and more! Best of all, join
us by working at a growing company like Talis with dedicated and
collaborative employees committed to making a difference in Health
Care.Talis is proud to be an equal opportunity workplace. All
aspects of employment decisions will be based on merit, competence,
performance, and business needs. We do not discriminate on the
basis of any status protected under federal, state, or local law.
We celebrate diversity and are committed to creating an inclusive
environment for our colleagues.More About Talis:Built on a
foundation of world-class science and engineering, we are
developing the Talis One platform, a sample-to-answer,
cloud-enabled molecular diagnostic platform that could be rapidly
deployed to distributed diagnostic settings in the United States
and around the world to diagnose infectious disease at the
point-of-care. The Talis One platform comprises a compact
instrument, single-use test cartridge, and innovative software
including a central cloud database. This system is designed to
provide central laboratory levels of accuracy and be operated by an
untrained user.Talis has raised more than $500 million to date and
went public in February 2021. We were granted Emergency Use
Authorization by the FDA for our Talis One TM COVID-19 Test System
in November 2021 and are in further testing stages and preparations
for commercial rollout.Associated topics: performance test,
process, qa, quality assurance, quality assurance analyst, quality
assurance engineer, software quality, software quality engineer,
test, tester
Keywords: Talis Biomedical, Redwood City , Vice President, QA/RA/Clinical (Redwood City), Other , Redwood City, California
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