Quality System Manager

About the Role

FYR Bio is seeking a collaborative, systems-minded leader and builder to strengthen the quality systems and operating disciplines required for our next stage of growth. This role combines hands-on Quality Management System (QMS) leadership with operational excellence, cross-functional project execution, and the scaling of regulated, high-throughput clinical laboratory workflows.

The ideal candidate can set direction, create structure, and work alongside teams to get important work done. They will build confidence and audit readiness while establishing practical measures, feedback loops, and continuous-improvement practices that strengthen compliance, reliability, throughput, and production efficiency.

Reporting directly to the Chief Operating Officer, this role partners closely with the Senior Director, Lab Operations; Head of Business Operations; Data, Software & IT teams; scientific and technical leaders; and client-facing teams. Functional leaders retain accountability for their teams, technical decisions, budgets, and day-to-day execution. This role owns the quality systems and cross-functional operating practices that make dependencies, readiness, risk, capacity, and follow-through visible.

What You'll Own

• Lead the day-to-day design, maintenance, and continuous improvement of FYR's QMS, including document control, training and competency, deviations, CAPA, change control, supplier quality, validation governance, equipment controls, and quality records.
• Translate applicable CLIA, FDA, ICH, GxP, sponsor, and contractual expectations into practical procedures, controls, decision rights, training, and retrievable evidence.
• Coordinate internal and external audits and inspections, including readiness plans, evidence indexes, staff preparation, responses, commitments, remediation, and closure tracking.
• Under the oversight of the COO/CLIA Laboratory Director, lead or co-lead pharmaceutical and biotechnology sponsor qualification meetings, client quality reviews, GxP audits, CLIA inspections, and other external assessments.
• Maintain quality metrics, management-review inputs, risk registers, and early-warning indicators; identify systemic improvements and escalate material quality, compliance, safety, or data-integrity risks.
• Partner with Data, Software & IT teams on access, audit trails, backup and restore, validation, change control, data integrity, and risk-based computerized-system controls.
• Partner with the Senior Director, Lab Operations to translate scientific, clinical, and client priorities into realistic plans, readiness gates, capacity scenarios, and handoffs; co-design changes affecting laboratory workflows or staff.
• Lead agreed cross-functional projects and laboratory scale-up initiatives using process mapping, root-cause analysis, standard work, visual management, Lean, Six Sigma, or comparable methods.
• Establish baselines and lead measurable improvements in throughput, turnaround time, first-pass success, rework, capacity utilization, equipment and labor use, and cost per sample - without compromising quality, safety, data integrity, or team sustainability.
• Maintain an authoritative portfolio-management view of priorities, owners, milestones, capacity assumptions, decisions, risks, dependencies, and completion evidence; bring unresolved tradeoffs to the COO with clear options and recommendations.
• Build readiness plans and evidence packages for priority clients, audits, inspections, assay or program milestones, and laboratory scale-up.
• Partner with the Head of Business Operations to connect quality, project, and scale-up plans to budgets, capital and personnel needs, procurement, supply chain, facilities, vendors, and organizational infrastructure.
• Create clear working agreements across functions, coach process owners in risk-based thinking and project discipline, and build confidence through transparency and reliable follow-through.
• Help establish controlled R&D/NPD-to-production handoffs. Routine production ownership is not included at hire, but the role may expand as FYR's production organization and volume grow.
• Bachelor's degree or higher in medical laboratory science, clinical laboratory science, medical technology, life sciences, engineering, quality, operations, or a related technical discipline.
• Typically seven or more years of progressive experience in regulated diagnostics, clinical laboratory services, life sciences, biopharma, medical devices, or a comparable regulated environment.
• Clinical-laboratory grounding through education or experience as a medical technologist, medical laboratory scientist, clinical laboratory scientist, or molecular-laboratory professional; an ASCP or equivalent credential, applicable state licensure, or substantial relevant continuing education is strongly valued.
• Demonstrated ownership of QMS processes and experience planning, conducting or co-leading, documenting, and following through on internal, supplier, sponsor/client, or regulatory audits in a GxP- or CLIA-regulated environment.
• Experience improving clinical, molecular, reference, or other regulated laboratory workflows, capacity, or production efficiency.
• At least two years leading programs, projects, process owners, or teams through direct or matrixed authority.
• Strong project/program management, capacity planning, problem-solving, change-management, facilitation, and written-communication skills.
• Sound judgment regarding segregation of duties and the distinction among operational, scientific, regulatory, statutory, and independent Quality decisions.
• A collaborative, team-first leadership style and the ability to create structure, confidence, and momentum while moving between strategic judgment and hands-on execution in a growing organization.
• Willing and able to work onsite in Missoula, Montana.
• Master's degree or other advanced education or training relevant to clinical laboratory science, quality systems, biotechnology, engineering, or operations.
• Direct experience scaling high-throughput clinical or molecular laboratory workflows through batching, standard work, capacity planning, automation, process redesign, or improved resource utilization.
• Experience supporting mass spectrometry-based proteomics or translational proteomics workflows, including sample preparation, LC-MS/MS operations, instrument qualification, method validation or verification, data analysis, or laboratory scale-up.
• Experience with molecular diagnostics, NGS, translational biomarkers, human biospecimens, or pharmaceutical sponsor-facing assay programs.
• Formal GxP auditor training or a recognized quality-auditor credential, such as RQAP, ASQ Certified Quality Auditor, or ISO 19011-based internal or lead-auditor training.
• PMP or comparable project/program-management training; Lean Six Sigma Green Belt or Black Belt; or another relevant quality, regulatory, or operational-excellence credential.
• Experience with eQMS, LIMS, ELN, portfolio-management, laboratory workflow-management, data-integrity, or computerized-system controls.

Required Qualifications

• Bachelor's degree or higher in medical laboratory science, clinical laboratory science, medical technology, life sciences, engineering, quality, operations, or a related technical discipline.
• Typically seven or more years of progressive experience in regulated diagnostics, clinical laboratory services, life sciences, biopharma, medical devices, or a comparable regulated environment.
• Clinical-laboratory grounding through education or experience as a medical technologist, medical laboratory scientist, clinical laboratory scientist, or molecular-laboratory professional; an ASCP or equivalent credential, applicable state licensure, or substantial relevant continuing education is strongly valued.
• Demonstrated ownership of QMS processes and experience planning, conducting or co-leading, documenting, and following through on internal, supplier, sponsor/client, or regulatory audits in a GxP- or CLIA-regulated environment.
• Experience improving clinical, molecular, reference, or other regulated laboratory workflows, capacity, or production efficiency.
• At least two years leading programs, projects, process owners, or teams through direct or matrixed authority.
• Strong project/program management, capacity planning, problem-solving, change-management, facilitation, and written-communication skills.
• Sound judgment regarding segregation of duties and the distinction among operational, scientific, regulatory, statutory, and independent Quality decisions.
• A collaborative, team-first leadership style and the ability to create structure, confidence, and momentum while moving between strategic judgment and hands-on execution in a growing organization.
• Willing and able to work onsite in Missoula, Montana.

Preferred Qualifications

• Master's degree or other advanced education or training relevant to clinical laboratory science, quality systems, biotechnology, engineering, or operations.
• Direct experience scaling high-throughput clinical or molecular laboratory workflows through batching, standard work, capacity planning, automation, process redesign, or improved resource utilization.
• Experience supporting mass spectrometry-based proteomics or translational proteomics workflows, including sample preparation, LC-MS/MS operations, instrument qualification, method validation or verification, data analysis, or laboratory scale-up.
• Experience with molecular diagnostics, NGS, translational biomarkers, human biospecimens, or pharmaceutical sponsor-facing assay programs.
• Formal GxP auditor training or a recognized quality-auditor credential, such as RQAP, ASQ Certified Quality Auditor, or ISO 19011-based internal or lead-auditor training.
• PMP or comparable project/program-management training; Lean Six Sigma Green Belt or Black Belt; or another relevant quality, regulatory, or operational-excellence credential.
• Experience with eQMS, LIMS, ELN, portfolio-management, laboratory workflow-management, data-integrity, or computerized-system controls.

About FYR Bio

FYR Bio is building scalable molecular and data-driven solutions for biomarker discovery, diagnostic development, and research services. We are expanding our work with pharmaceutical partners while advancing CLIA and GxP readiness and building the operating capabilities needed for dependable growth. We are energized by technology that can strengthen diagnostics, evidence, and patient care.

FYR Bio is an Equal Opportunity Employer.