Quality Manager

Labcorp•Hoover, AL

About The Position

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 assigned laboratory or geographic region. This role leads the internal and external audit program and the resolution of audit and inspection findings, manages the internal and external proficiency testing program, oversees the nonconforming event 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 and works closely with operations staff to ensure alignment with quality system policies and business initiatives.

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 supervisory experience preferred
Diagnostics Laboratory experience strongly preferred.
Strong understanding of compliance with CLIA, CAP, ISO 15189, and other regulatory and accreditation requirements
Quality Certification preferred (e.g. Six Sigma Green Belt or higher, ASQ Certifications, auditor certification)

Responsibilities

Cultivates and promotes a strong commitment to quality.
Partners with lab leaders to establish and align quality goals and strategic objectives
Ensures all laboratories within the assigned area(s) maintain current federal, state, and local licensure and accreditations, as applicable.
Provides guidance for laboratories on implementing policies and procedures with respect to regulatory and accreditation requirements.
Audits laboratory practices to identify nonconformities, quality concerns, and areas for improvement.
Facilitates onsite audits and inspections including responding to accreditation and regulatory citations, nonconforming events, and formal complaints.
Manages the non-conforming event program including, supporting investigations and root cause analysis efforts, providing guidance on action plans, tracking and trending outcomes, ensuring effectiveness checks are completed to ensure resolution and improvement.
Tracks the outcomes of root cause analyses, corrective actions, and effectiveness checks to ensure resolution and improvement.
Prepares and leads quality meetings, document minutes, and communicate progress on key performance indicators.
Provides and ensures training on quality policies and procedures including but not limited to new hire quality orientation and CLIA delegation responsibilities/supervisor training.
Participates in regulatory inspections and interfaces with auditors; coordinates responses with the necessary stakeholders.
Provides leadership, direction, and support to team members to ensure quality excellence and outcomes.
Fosters a collaborative and accountable work environment.
Collects and summarizes data for management reports, including quality indicators, audit results, and complaint trends.
Leads initiatives to enhance laboratory processes and drive continuous improvement.
Facilitates risk management program including performing risk assessments, communicating risks to leaders, and following up on mitigation plans.
Participates in special Projects: As directed by supervisor.
Partners with laboratory leaders to identify, implement, and track improvement opportunities.
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 interprets 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.
Follows the direction of the Division Quality Director to maintain the overall Quality Management Program of the laboratory.