The Divisional Quality Manager position will provide quality management oversight for clinical diagnostic and biological donor testing performed at National Genetics Institute (NGI) within the LabCorp family. NGI is accredited by CAP, is regulated by several US and non-US governmental agencies, and holds licenses from NY and several other states. The Quality Manager is responsible for the activities of a QA/QC department staff of 10 FTEs and reports to the off-site Quality Director for the Esoteric Business Units. The Quality Manager will foster a collaborative and proactive environment for ensuring quality delivery of products and services.
Functional responsibilities include:
Leads quality and regulatory strategy; oversees the creation, execution, and maintenance of the quality management system policies and procedures; and manages the day-to-day activities of the quality department.
Keeps abreast of new or revised applicable international, national, state, and local requirements for licensing, certifying, and accrediting agencies. Communicates information clearly, succinctly, and in a timely manner throughout the facility.
Assists with identifying, remediating, and documenting quality issues per established protocols.
Oversees the internal audit program and participates as an auditor.
Responsible for review of findings, responses to external auditing agencies, and evaluation of the effectiveness of corrective actions.
Prepares monthly reports for senior operations leadership for management reviews.
Laboratory Corporation of America is the nation’s premier clinical and anatomic testing laboratory. At LabCorp, we understand what's important - it's the people whose lives we help improve that matter most. We connect our company and our people in ways that few companies can. Each day, our team members have an opportunity to build rewarding careers and experience the satisfaction of knowing the work they do helps save lives. If you're looking for a career that offers opportunities for growth, continual development, professional challenge and the chance to make a real difference, connect to LabCorp. Connect to something amazing.
Must possess a Bachelor’s degree in a biological or chemical science
7-10 years of quality management experience in a clinical diagnostic laboratory
3-5 years supervision of at least 8 direct reports
Strong knowledge of root cause analysis and risk assessment process
Experience as an auditor and project facilitator
Prior experience and knowledge of FDA regulations for blood /plasma donor testing, preferred
Must possess excellent leadership, organizational and time management, problem solving, written and verbal communication skills
National Genetics Institute (NGI) provides advanced genetics testing services for blood screening, medical testing, and clinical research. The company offers industry leading assays for human immunodeficiency virus (HIV), hepatitis A, B, and C (HAV, HBV, and HCV) viruses and other infectious agents and has pioneered robust, sensitive, and high throughput methods for pooled specimen nucleic acid te...sting. NGI is licensed as a clinical laboratory provider by both state and federal agencies, participates in a number of approved quality control programs, and holds active Biologics Licenses from the US Food and Drug Administration (FDA) for screening of plasma for HCV, HIV-1. and HBV.