Vice President, QA/RA/Clinical
Company: Talis Biomedical
Location: Palo Alto
Posted on: June 17, 2022
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
- 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
- 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
- Ongoing development of Quality Management System (QMS),
including SOP creation, adhering to FDA and GxP requirements,
training, management, and oversight of audits &
- Support overall business strategy by maintaining robust
regulatory compliance, develop quality standards, establish vendor
and external KOL relationships, and ensure inspection-readiness at
- 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
- Developed strong relationships with regulatory
- 5+ years of direct management experience.
- Able to organize, prioritize and execute to achieve company
- Proficiency with ISO 13485, MDSAP, IVDR and GxP
- 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
- Cross functional leadership skills for interaction with
internal executive team members, as well as with external Board of
Directors, investors, and other 3rd 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 OneTM COVID-19 Test System
in November 2021 and are in further testing stages and preparations
for commercial rollout.
Keywords: Talis Biomedical, Palo Alto , Vice President, QA/RA/Clinical, Accounting, Auditing , Palo Alto, California
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