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Laboratory Quality System Manager Jobs (NOW HIRING)

FYR Diagnostics

Quality System Manager

Missoula, MT · On-site

$85K - $110K/yr

This role combines hands-on Quality Management System (QMS) leadership with operational excellence ... Under the oversight of the COO/CLIA Laboratory Director, lead or co-lead pharmaceutical and ...

SEACORP

Quality System Manager

Norfolk, VA · On-site

SEACORP is seeking a well-qualified Quality System Manager . Primary Duties and Responsibilities: Job Summary : Plan, direct, and coordinate quality assurance administration programs of the company ...

Supermicro

Quality System Manager

San Jose, CA · On-site

$105K - $135K/yr

The Quality Management Systems Manager will provide leadership in the implementation, maintenance, and improvement of company-wide Quality Management System, Environmental Management System (EMS ...

Stefanini, Inc

Quality Manager

Portland, OR · On-site

Laboratory Testing / Analytical Sciences Position Overview We are seeking an experienced Quality Assurance Manager to lead and maintain the Quality Management System for an established analytical ...

Motive Companies

Quality Manager

Portland, OR · On-site

Laboratory Testing / Analytical Sciences Position Overview We are seeking an experienced Quality Assurance Manager to lead and maintain the Quality Management System for an established analytical ...

AmSpec Group

QA Manager

Gonzales, LA · On-site

... Laboratory Quality System Manual (LQSM). • Prepare for internal, customer, and regulatory ... Manager maintain all records for review. • Controlling the laboratory equipment and supply ...

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Laboratory Quality System Manager information

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How much do laboratory quality system manager jobs pay per year?

As of Sep 11, 2026, the average yearly pay for laboratory quality system manager in the United States is $91,960.00, according to ZipRecruiter salary data. Most workers in this role earn between $70,000.00 and $111,000.00 per year, depending on experience, location, and employer.

What is a laboratory quality system manager?

Laboratory Quality System Managers are professionals responsible for developing, implementing, and overseeing quality management systems in laboratory settings. They ensure that laboratory processes comply with regulatory standards, such as ISO 17025 or CLIA, to guarantee the accuracy and reliability of test results. Their duties often include conducting audits, managing documentation, training staff on quality procedures, and facilitating continuous improvement. By maintaining high standards, they help laboratories achieve accreditation and deliver trustworthy results to clients and stakeholders.

What are the key skills and qualifications needed to thrive as a laboratory quality system manager?

To thrive as a Laboratory Quality System Manager, you need a strong background in laboratory science, quality management principles, and typically a bachelor's degree in a scientific field, often with additional training in quality systems. Familiarity with ISO 15189, CLIA regulations, LIMS (Laboratory Information Management Systems), and quality audit methodologies is essential, with certifications like ASQ Certified Quality Manager being advantageous. Leadership, meticulous attention to detail, and strong communication skills help coordinate teams and ensure compliance across laboratory processes. These skills and qualifications are critical for maintaining laboratory accreditation, ensuring accurate results, and driving continuous improvement in quality standards.

What are some of the key challenges a laboratory quality system manager faces when implementing new quality standards across diverse laboratory teams?

A Laboratory Quality System Manager often encounters the challenge of aligning multiple teams with varying processes and levels of experience to new or updated quality standards. This requires clear communication, comprehensive training, and effective change management to ensure all team members understand and adhere to new protocols. Additionally, balancing regulatory compliance with daily laboratory operations can be demanding, as it may involve adapting workflows without disrupting ongoing research or testing. Successful managers leverage collaboration, regular audits, and feedback mechanisms to foster a culture of continuous improvement.

What are popular job titles related to Laboratory Quality System Manager jobs?

For Laboratory Quality System Manager jobs, the most frequently searched job titles are:

Infographic showing various Laboratory Quality System Manager job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 81% Full Time, 13% Part Time, 4% Contract, and 1% Nights. Highlights an 84% Physical, 1% Hybrid, and 15% Remote job distribution, with an average salary of $91,960 per year, or $44.2 per hour.

Quality System Manager

Missoula, MT • On-site

FYR Diagnostics
Biotechnology Research and Development • 11 - 50 employees
Learn more about FYR Diagnosticsexternal

$85K - $110K/yr

Full-time

Posted 18 days ago

Job description

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.

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