Quality Manager

Labcorp•Dallas, TX

7d•Onsite

About The Position

Labcorp has a Quality Manager position in Dallas, TX. Schedule: Monday – Friday 8am-5pm. Labcorp is a global leader in diagnostic testing and drug development solutions, helping healthcare providers, researchers, and patients make informed decisions that advance care. Join us in our mission to improve health and improve lives. The Quality Manager is responsible for the Quality programs, systems, processes, and procedures and that the performance and quality of services conform to established regulatory and accreditation requirements within the assigned laboratory or geographic region. The Quality Manager leads the internal and external audit program and resolution of audit and inspection findings; manages the internal and external proficiency testing program, manages the nonconforming event program, and facilitates continuous improvement. Oversees compliance with CLIA, CAP, ISO 15189, and other regulatory and accreditation requirements. This position is responsible for the quality programs, systems, processes, and procedures used to ensure that the lab(s)’s performance and quality of services conform to established regulatory and accreditation requirements within the Labcorp Dallas, TX Regional laboratory or geographic region. The quality manager is responsible for quality system management. This role leads the internal and external audit program, manages the internal and external proficiency testing program, oversees the nonconforming event program, document control, proficiency testing, staff credentialing, site licensure/accreditation programs, risk management, change control program, and facilitates continuous improvement. The manager ensures compliance with CLIA, CAP, ISO 15189, and other applicable regulatory and accreditation requirements. The position promotes a culture of quality which includes providing training and guidance on quality related topics, and works closely with operations staff to ensure alignment with quality system policies and business initiatives. The role also has direct reports.

Requirements

BA/BS degree in Biology, Chemistry, Medical Technology, or other related science
5+ years in Quality Assurance and/or Quality Management

Nice To Haves

2 years of People Leadership Operations experience, preferred.
Diagnostics Laboratory experience strongly preferred.
Strong understanding of compliance with CLIA, CAP, ISO 15189, and other regulatory and accreditation requirements.

Responsibilities

Communicates a shared vision to reach current and future goals.
Promotes a culture of quality and create an environment for ongoing learning and development.
Provides and ensures training for Labcorp quality policies and procedures.
Serves as a liaison between external regulatory agencies and laboratories.
Facilitates process improvement activities.
Monitors and interpretate outcomes of root cause analysis, corrective action, and effectiveness checks.
Maintains a contemporary knowledge of current industry trends, standards, and methodologies.
Formulates responses to accreditation and regulatory citations, nonconforming events, and complaints.
Provides guidance for laboratories in implementing policies with respect to regulatory and accreditation requirements.
Collects summary data for management reports: quality indicators, audit outcomes, and complaints and presents to leadership.
Audits laboratories to identify quality issues, nonconformities, and opportunities for improvement.
Leads the internal and external audit program and resolution of audit and inspection findings.
Manages the internal and external proficiency testing program.
Manages the nonconforming event program.
Facilitates continuous improvement.
Oversees compliance with CLIA, CAP, ISO 15189, and other regulatory and accreditation requirements.
Leads the internal and external audit program.
Manages the internal and external proficiency testing program.
Oversees the nonconforming event program, document control, proficiency testing, staff credentialing, site licensure/accreditation programs, risk management, change control program.
Ensures compliance with CLIA, CAP, ISO 15189, and other applicable regulatory and accreditation requirements.
Promotes a culture of quality which includes providing training and guidance on quality related topics.
Works closely with operations staff to ensure alignment with quality system policies and business initiatives.