CMOCO/CGL Laboratory Compliance and Quality Manager

Job Summary:

Colorado Molecular Correlates Laboratory (CMOCO) and Colorado Genetics Laboratory (CGL) are state-of-the-art clinical molecular diagnostic and cytogenetic laboratories, both owned and operated by the Department of Pathology within the University of Colorado Anschutz School of Medicine. CMOCO is dedicated to the clinical practice of molecular diagnostic medicine, performing molecular testing on cancer and constitutional cells and tissues to generate predictive, prognostic, and diagnostic molecular biomarker data across a spectrum of platforms including next generation sequencing (NGS) and targeted testing. CGL provides comprehensive conventional and molecular cytogenetic testing services for constitutional (prenatal and postnatal) and oncology disorders. CGL's testing platforms include chromosome analysis, fluorescence in situ hybridization (FISH), and chromosomal microarray. The laboratories are CLIA certified and accredited by the College of American Pathologists. Both laboratories are staffed by clinical faculty and highly skilled technologists, and operate under validated protocols, including FDA approved assays and laboratory developed tests used for patient care. Laboratories are located in the Biosciences 2 building on the Anschutz Campus.

CMOCO and CGL are high-complexity clinical laboratories that perform high volume molecular and cytogenetic testing and serve as reference laboratories hospitals, and healthcare facilities across Colorado and the United States.

The Laboratory Compliance and Quality Manager is a joint position shared between CMOCO and CGL. This position will oversee and coordinate all aspects of laboratory quality for both laboratories, including adherence to CLIA regulations for high-complexity testing, maintenance of CAP accreditation, and compliance with University of Colorado policies and procedures. Major responsibilities include developing, implementing, and maintaining the quality management system, quality assurance, quality control, and quality improvement programs; managing document control systems; monitoring and trending laboratory metrics to support high quality patient care; overseeing non-conforming event reporting and investigation; and ensuring that both laboratories remain inspection ready. The role also includes proactive workflow evaluation and process improvement initiatives to enhance regulatory compliance, operational efficiency, and test quality. This position requires close coordination and collaboration with CMOCO and CGL Laboratory Managers, Directors, and technologists to ensure a cohesive and effective quality management system in both laboratories.

Key Responsibilities:

• (20%) Documenting, maintaining, and updating laboratory quality management systems for CMOCO and CGL, including assay quality control and assurance, proficiency testing, instrument performance monitoring, and personnel compliance records such as education, certification, and competency assessment

• (20%) Overseeing document control to support the quality management systems for CMOCO and CGL

• (15%) Serving as a subject matter expert and leader in regulatory compliance and quality assurance including, monitoring relevant regulatory changes, coordinating CAP inspections, and communicating regulatory requirements and changes to the laboratory

• (15%) Participating in data management, analysis, and statistical reporting of quality metrics, including identifying trends and opportunities for improvement

• (15%) Participating in and leading workflow evaluation and process improvement initiatives to enhance laboratory efficiency, quality, and compliance

• (10%) Leading the reporting, investigation, and resolution of non-conforming events, including root cause analysis and implementation of corrective and preventive actions to facilitate continuous quality improvement in both laboratories

• (5%) Performing additional quality and compliance related activities as required to support laboratory operations

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.

Why Join Us:

Welcome to the Department of Pathology of the University of Colorado, Anschutz Medical Campus. The Department has grown substantially in the past 15 years, from 40 to 120 faculty in parallel with the remarkable growth of our hospital-based affiliates as well as the city and county of Denver. Our work is value driven and focused on scientific investigation, lifelong learning, and a balance of personal and professional values. In addition to a vibrant and highly competitive residency program with 25 positions, we offer 9 fellowships and participate in numerous graduate schools and the MD/PhD program of the CU School of Medicine.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

• Medical: Multiple plan options

• Dental: Multiple plan options

• Additional Insurance: Disability, Life, Vision

• Retirement 401(a) Plan: Employer contributes 10% of your gross pay

• Paid Time Off: Accruals over the year

• Vacation Days: 22/year (maximum accrual 352 hours)

• Sick Days: 15/year (unlimited maximum accrual)

• Holiday Days: 10/year

• Tuition Benefit: Employees have access to this benefit on all CU campuses

• ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Qualifications:

Minimum Qualifications:

• A bachelor's degree from an accredited institution

• 4 years of professional experience in laboratory quality control, quality assurance, and regularity compliance

• Experience with Next Generation Sequencing (NGS) and/or chromosomal microarray

• Certification by ASCP in cytogenetics (CG) or Molecular (MB) OR certification by quality management professional bodies (e.g. ASQ, RAC, LQMS, etc.) or equivalent

• An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.

Applicants must meet minimum qualifications at the time of hire. Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

Preferred Qualifications:

• Experience in establishing and maintaining clinical laboratory quality management systems, including but not limited to: IQ/OQ, proficiency testing, competency assessment, non-conforming events, document control.

• Experience analyzing laboratory data using qualitative, quantitative and statistical methods including but not limited to: regression analysis, Westgard rules, confidence intervals, Levey-Jennings analysis, root cause analysis, fishbone analysis

• Experience in national regulatory requirements related to molecular diagnostics and cytogenetics, including but not limited to: DexZ/MolDx code submission, laboratory developed tests, inspection from accrediting agencies (CAP, The Joint Commission, etc.)

• Experience working with laboratory information systems or electronic data systems.

• 5 years experience working in a high-complexity clinical laboratory.

• Previous experience in personnel supervision

Knowledge, Skills and Abilities:

• Ability to communicate effectively, both in writing and orally.

• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

• Outstanding customer service skills.

• Proficiency in paperless workflows

• Willing and capable of learning techniques for histology, cytogenetics, and molecular pathology

• Ability to interpret and apply complex regulatory requirements, policies, procedures, and guidelines

• Ability to organize workload, file correctly by alphabetical and numerical order

• Maintains a professional demeanor, demonstrates problem solving skills, and exhibits strong technical and analytical skills

• Self-motivated with excellent time management and communication skills

• Strong organizational skills and ability to manage multiple priorities and deadlines

• Familiarity with HIPPA and data security requirements

• Knowledge of laboratory operations, instrumentation, safety practices, and regulatory requirements in a highly complex laboratory setting

• Good knowledge of hospital organization and functions.

• Good knowledge of high-complexity laboratory regulation and licensing, including knowledge of costs associated with a laboratory.

• Skilled in managing a quality management system.

• Ability to implement quality control standards.

• Ability to perform root cause analysis and implement corrective and preventive actions.

• Ability to construct technical and administrative reporting procedures.

• Ability to communicate effectively with technologists, staff, physicians, trainees, and faculty.

• Ability to coordinate the work of others.

• Ability to read, write, speak, understand, and communicate in English sufficiently to perform the essential duties of the position.

• Proficiency in computer applications including spreadsheets, word processing, and database systems.

• Professional judgment, discretion, and ability to handle sensitive information appropriately.

How to Apply:

For full consideration, please submit the following document(s):

1. Curriculum vitae / Resume

2. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: PathHR at PathHR@cuanschutz.edu

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by June 30, 2026. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as:

$89,476 to $113,992

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator

Equal Employment Opportunity Statement:

CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply, including protected veterans and individuals with disabilities.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.