About the Company

Our purpose at Talis Biomedical 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

Sr. Director, Quality (Medical Device/IVD)

SUMMARY OF POSITION

The primary function of the Senior Director, Quality is to provide leadership to assure the successful execution of Talis’ Quality program and to be responsible for developing, implementing, and advising on strategies for development programs

POSITION RESPONSIBILITIES

Directs Talis’ Quality function responsible for the Company’s Quality System compliance with applicable regulatory agencies, Quality pre-market product and operations support, and strong functional leadership. Upon product launch, will be responsible for post-market Quality System compliance, post market surveillance including complaint monitoring, tracking and trending and resolution with Commercial.
Sets the strategy to meet quality system, validation of design and design change. Champions design control rigor throughout the product lifecycle.
Leads the Quality Department including setting priorities and staffing. Hires, develops and assures the Quality Department staff reviews/approves quality documents that are in alignment with site Quality System and procedures.
Implements, administers, and maintains the Company’s document control system and responsible for training of employees, and writing and updating Quality procedures.
Responsible for risk management (CAPA, Corrective Action Board, and non-conformity management) and change control activities.
Implements processes and procedures such as vendor audits, testing, etc., necessary to support product portfolios.
Works with a broad range of internal functional groups including Operations, R&D, Project Management, and Product Management.
Works closely with internal groups and outside agencies, as required, to assure compliance with regulations as part of the development and commercialization of the Company’s intended clinical diagnostic products. Works with regulators related to product quality matters, as identified.
Serves as a key focal point and participant in audits by external certifying bodies and/or regulatory agencies. Directs and/or participates in vendor audits to assure conformity to stated specifications.
Works closely with Project Management to ensure Quality compliance with design control and product development processes. Provides oversight for product non-conformance situations and assure adequate investigation, correction action and close out actions implemented.
Drives best practices and tools to improve execution and quality. Drives a culture of efficiency and accountability.
Provides project and department updates to the executive team and advises senior management on action plans related to product quality and safety.

QUALIFICATIONS

BS degree or equivalent, preferably in a Quality, Regulatory, Engineering or scientific/technical area. A minimum of 8-10 years progressive Quality, Regulatory Affairs, and technical experience.
IVD and molecular diagnostics experience required; Point of care (POC) regulated device experience.
A proven track record of having built and managed Quality and Regulatory teams.
Thorough knowledge of QSR/QSIT and ISO13485.
Product labeling expertise.
Proficiency related to the incorporation of Quality elements as part of a phase gate process for development and launch of commercial products.
Experience in CAPA and implementing quality and business processes improvement required.
Must be able to provide sound quality direction to set strategy and solve problems.
Proven structured thinking to accurately evaluate and assess processes and problems, identify and articulate possible solutions and drive to resolution.
Demonstrated leadership to assure a well-developed Quality System and participation in audits by external certification or regulatory agencies.
Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas.
Prior experience with IVD assay registration processes required.

Communication & Interpersonal Skills:

Excellent verbal and written skills; able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
Strong negotiating skills and ability to think creatively and develop creative solutions.
Proven ability to build trust and respect within the organization.
Ability to prioritize and handle multiple projects.
Interacts with external business partners and Regulatory Agencies.

This role will be based in either Chicago, IL or Redwood City, CA. Target compensation range for a Bay-area California hire is between $240-$275k, commensurate with overall experience. Meeting minimum requirements does not guarantee the highest end of the range.

Some remote/ work may be permitted.

Talis Biomedical 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, Happy Hours, office perks, and other fun company events! 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 Biomedical 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. Talis Biomedical is an E-Verify Participation company.

More About Talis Biomedical:

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.

Average Compensation: $135,384

How Much Do Talis Biomedical Employees Make?