Vice President, QA/RA/Clinical

Company: Talis Biomedical
Location: Fremont
Posted on: June 18, 2022

Job Description:

About the Company

Our 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 Trust

The 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.

Keywords: Talis Biomedical, Fremont , Vice President, QA/RA/Clinical, Executive , Fremont, California