Vice President Operations

HepQuant, LLC; Denver (CO); Hybrid; USD 180,000 - 230,000; Full time

Job summary

HepQuant, LLC in Denver, CO seeks a hands-on Vice President of Operations to lead Manufacturing & Supply Chain, Laboratory Operations, Quality & Regulatory Operations, and Operational Excellence. Reports to CEO/President, driving scalability and commercialization readiness in a regulated diagnostics environment.

The ideal candidate has 8+ years in regulated healthcare operations, startup and commercialization experience, and a track record of scaling processes within a growing company.

Qualifications

• 8+ years of operational leadership experience within medical device, diagnostics, biotech, pharmaceutical, or other regulated healthcare industries.
• Start-up and commercial launch experience within biotechnology or pharmaceutical environments preferred
• Demonstrated experience scaling operational processes and improving organizational efficiency within a growing company

Responsibilities

• Lead Manufacturing & Supply Chain, Laboratory Operations, Quality & Regulatory Operations, and Operational Excellence
• Develop and scale operational processes, systems, and infrastructure to support growth and commercialization readiness
• Partner cross-functionally with Quality, Regulatory, Commercial, Finance, and Executive leadership to drive alignment and execution
• Support operational readiness activities related to FDA submissions, compliance initiatives, and commercialization planning
• Establish operational metrics, reporting tools, and performance dashboards to improve visibility and accountability
• Drive operational efficiency and continuous improvement initiatives across the organization
• Assist with operational planning, resource allocation, and prioritization across departments
• Build and mentor high-performing teams while fostering a collaborative and accountable culture

Skills

Operational leadership

Startup experience

Regulated healthcare

Cross-functional collaboration

Job description

HepQuant is an early commercial-stage diagnostic company and clinical laboratory with headquarters in Denver and a CLIA lab in Aurora, Colorado. We recently launched our first Laboratory Developed Test (LDT) to the US market and are focused on scaling operations and preparing for reimbursement expansion. HepQuant develops non-invasive, quantitative tests that measure liver health. The HepQuant DuO Test is a LDT that enables healthcare providers to manage patients with liver diseases more effectively. It delivers information about liver cell function and portal-systemic shunting, attributes of liver disease that are associated with clinical outcomes. Results may be used by a physician in conjunction with clinical evaluation and other tests to aid in the decision to proceed with or defer invasive procedures, to monitor treatment response, or to predict disease progression and adverse outcomes, such as ascites, encephalopathy, and variceal bleeding.

Job Duties

We are seeking an experienced and collaborative Vice President of Operations to join our leadership team. This individual will lead key operational functions across the organization and help drive operational excellence, scalability, and commercialization readiness within a growing medical device/diagnostics company.

The VP of Operations will work closely with executive leadership to strengthen operational infrastructure, improve cross-functional execution, and support the company’s continued growth. The ideal candidate is a hands-on operational leader with experience in regulated healthcare, medical device, diagnostics, or biotech environments who thrives in an entrepreneurial organization.

This position reports directly to the CEO and President.

Primary Responsibilities

• Lead operational functions across Manufacturing & Supply Chain, Laboratory Operations, Quality & Regulatory Operations, and Operational Excellence
• Develop and scale operational processes, systems, and infrastructure to support organizational growth and commercialization readiness
• Partner cross-functionally with Quality, Regulatory, Commercial, Finance, and Executive leadership teams to drive operational alignment and execution
• Support operational readiness activities related to FDA submissions, compliance initiatives, and commercialization planning
• Establish operational metrics, reporting tools, and performance dashboards to improve visibility, accountability, and decision-making
• Drive operational efficiency and continuous improvement initiatives across the organization
• Assist with operational planning, resource allocation, and prioritization across departments
• Build and mentor high-performing teams while fostering a collaborative and accountable culture

Year 1 Priorities

• Strengthen operational infrastructure and cross-functional execution across the organization
• Support operational readiness activities related to FDA approval and commercialization efforts
• Improve operational reporting, planning, and process consistency across key departments
• Enhance scalability of manufacturing, laboratory, and operational support functions

Qualifications

• 8+ years of operational leadership experience within medical device, diagnostics, biotech, pharmaceutical, or other regulated healthcare industries
• Start-up and commercial launch experience within biotechnology or pharmaceutical environments preferred
• Demonstrated experience scaling operational processes and improving organizational efficiency within a growing companyStatus: Full-Time

  Location: Denver, CO- onsite preferred, but hybrid/remote will be considered for the right candidate

  Travel: Position will require approximately 5-10% travel (domestic & international) via airplane, car, and overnight stays.