Divisional Quality Manager – National Genetics Institute
Los Angeles, California
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.
Must possess a Bachelor’s degree in a biological or chemical science
Must have 7-10 years of quality management experience in a clinical diagnostic laboratory and/or the FDA regulated pharmaceutical or medical device industry
Prior experience and knowledge of regulations applicable to blood/plasma donor testing, preferred
Must have 3-5 years of experience in supervision of at least 8 direct reports
Must have strong knowledge of root cause analysis and risk assessment process
Must have experience as an auditor and project facilitator
Must possess excellent leadership, organizational and time management, problem solving, written and verbal communication skills
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.
Internal Number: 64420
LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services.
With a mission to improve health and improve lives, LabCorp delivers world-class diagnostic solutions, brings innovative medicines to patients faster and uses technology to improve the delivery of care. LabCorp reported net revenues of over $10 billion in 2017.