Description

1 of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at Indiana University (IU) School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for National Institutes of Health (NIH) Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.

Job Summary

The Compliance, Quality, and Regulatory Supervisor works with the laboratory leadership to provide regulatory oversight to all sections of the IU Genetic Testing Laboratories (IUGTL). This includes monitoring key indicators of quality in the pre-analytic, analytic, and post-analytic phases by regularly comparing performance against targets defined by the laboratory leadership. They support the laboratory's regulatory readiness and quality management activities to ensure full compliance with Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), state, and institutional requirements.
Department-Specific Responsibilities

• Works with the lab manager to coordinate inspection preparedness.
• Oversees quality documentation and audits.
• Works closely with laboratory leadership to maintain continuous improvement in quality systems.
• Assists with drafting and revising laboratory policies and procedures to align with regulatory standards.
• Monitors nonconformances.
• Implements corrective and preventive actions (CAPAs).
• Leads improvement initiatives.
• Collaborates with section supervisors to ensure training and competency assessment documentation meets regulatory requirements.
• Partners with the Laboratory Manager and Director to implement quality improvement initiatives.
• Serves as a resource to staff and supervisors on compliance questions.
• Assists with proficiency testing reporting and review.

General Responsibilities

• Provides day-to-day operational management of laboratory.
• Establishes laboratory's short-term operational objectives.
• Identifies laboratory operational issues and/or areas of improvement and implements solutions to improve processes and/or operational efficiency.
• Analyzes, monitors, and evaluates laboratory performance of assigned staff; establishes work priorities, conducts performance reviews, and provides corrective action as needed.
• Ensures adequate laboratory staffing and effective scheduling; participates and informs employment decisions for assigned staff.
• Provides direct laboratory supervision and oversight of assigned staff and activities; impacts, and is held accountable for, the performance of team and/or assigned staff.
• Ensures and provides training to assigned staff to improve laboratory operations; researches and identifies development opportunities for assigned staff.
• Researches and stays up to date on new industry standards in diagnostic genomics, best practices, and emerging technology; keeps next-level leader(s) informed of trends as well as significant problems.

Qualifications

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

EDUCATION
Required

• Bachelor's degree (preferably in a related science field)

WORK EXPERIENCE
Required

• 2 years in a clinical genetic testing lab

Preferred

• 5 years in a clinical genetic testing lab
• Laboratory leadership experience/training

SKILLS
Required

• Proficient in written and verbal communication skills
• Maintains a high degree of professionalism
• Demonstrated time management and priority setting skills
• Demonstrates a high commitment to quality
• Excellent organizational skills
• Excellent collaboration and team building skills
• Effectively coaches and delivers constructive feedback
• Instills commitment to organizational goals

Working Conditions / Demands

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.

Work Location

Indiana University Indianapolis
Indianapolis, Indiana

Advertised Salary

$80,076.00 - $86,076.00 annually, based on experience and internal equity within the department.

Benefits Overview

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)

Learn more about our benefits by reviewing the IU Benefit Programs Brochure .

Job Classification

Career Level: Operational
FLSA: Exempt
Job Function: Health Services
Job Family: Clinical Laboratory
Click here to learn more about Indiana University's Job Framework.

Posting Disclaimer

This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.

Equal Employment Opportunity

Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information .

Campus Safety and Security

The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online . You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.