Indiana University
Compliance, Quality, and Regulatory Supervisor (Genetics Laboratory Leader)
Indiana University, Indianapolis, Indiana, us, 46262
Compliance, Quality, and Regulatory Supervisor (Genetics Laboratory Leader)
5 days ago – Be among the first 25 applicants
MMGE – GENE TESTING LAB (IN‑GTL‑IUINA)
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.
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.
Education
Bachelor's degree (preferably in a related science field)
Work Experience
2 years in a clinical genetic testing lab (required)
5 years in a clinical genetic testing lab (preferred)
Laboratory leadership experience/training (preferred)
Skills
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
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.
Indiana University Indianapolis, Indianapolis, Indiana
$80,076.00 – $86,076.00 annually, based on experience and internal equity within the department.
Benefits
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.
Career Level: Operational FLSA: Exempt Job Function: Health Services Job Family: Clinical Laboratory
Click here to learn more about Indiana University's Job Framework.
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.
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.
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.
Request Support – Telephone: 812‑856‑1234
#J-18808-Ljbffr
MMGE – GENE TESTING LAB (IN‑GTL‑IUINA)
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.
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.
Education
Bachelor's degree (preferably in a related science field)
Work Experience
2 years in a clinical genetic testing lab (required)
5 years in a clinical genetic testing lab (preferred)
Laboratory leadership experience/training (preferred)
Skills
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
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.
Indiana University Indianapolis, Indianapolis, Indiana
$80,076.00 – $86,076.00 annually, based on experience and internal equity within the department.
Benefits
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.
Career Level: Operational FLSA: Exempt Job Function: Health Services Job Family: Clinical Laboratory
Click here to learn more about Indiana University's Job Framework.
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.
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.
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.
Request Support – Telephone: 812‑856‑1234
#J-18808-Ljbffr