Quality Systems Leader, GxP/CLIA Compliance

FYR Diagnostics; Missoula (MT); On-site; USD 140,000 - 190,000; Full time

Job summary

FYR Bio in Missoula, MT seeks a systems‑minded leader to scale our quality management system and operating disciplines for growth. You will own QMS design, audits, and cross‑functional execution, partnering with COO, Lab Operations, and IT teams to ensure readiness, data integrity, and compliant, high‑throughput workflows.

The role requires seven+ years in regulated diagnostics or related fields, leadership experience, and a track record of implementing quality systems and continuous improvement

Qualifications

• Bachelor's degree or higher in medical laboratory science, clinical laboratory science, life sciences, engineering, quality, operations, or related technical discipline.
• Seven+ years of progressive experience in regulated diagnostics, clinical laboratory services, life sciences, biopharma, medical devices, or similar regulated environments.
• Clinical‑laboratory grounding with ASCP or equivalent credential, licensure, or continued education valued.
• Ownership of QMS processes and audits in a GxP- or CLIA‑regulated environment.
• Experience improving regulated lab workflows, capacity, or production efficiency.
• At least two years of leadership experience.

Responsibilities

• Lead the day‑to‑day design, maintenance, and continuous improvement of FYR's QMS and quality records.
• Translate CLIA, FDA, ICH, GxP requirements into practical procedures, controls, and retrievable evidence.
• Coordinate internal and external audits and inspections with readiness plans and responses.
• Lead sponsor qualification meetings, client quality reviews, and external assessments.
• Maintain quality metrics, risk registers, and early‑warning indicators; drive improvements.
• Partner with Data, Software & IT on access controls, data integrity, and system validation.
• Collaborate with Lab Operations to translate priorities into ready plans and capacity scenarios.
• Lead cross‑functional projects and lab scale‑up using Lean/Six Sigma and process mapping.
• Establish baselines and measurable improvements in throughput, turnaround time, and cost per sample.

Skills

Leadership

Project management

Quality systems

Auditing

Data integrity

Change management

Cross-functional collaboration

Education

Bachelor's degree or higher in medical laboratory science or related field

Master's degree or advanced training

Tools

eQMS

LIMS

ELN

Portfolio management tools

Job description

FYR Bio in Missoula, MT seeks a systems‑minded leader to scale our quality management system and operating disciplines for growth. You will own QMS design, audits, and cross‑functional execution, partnering with COO, Lab Operations, and IT teams to ensure readiness, data integrity, and compliant, high‑throughput workflows.

The role requires seven+ years in regulated diagnostics or related fields, leadership experience, and a track record of implementing quality systems and continuous improvement