The Divisional Quality Manager position will provide regulatory and quality management oversight for patient and donor testing performed at National Genetics Institute (NGI) within the LabCorp family. NGI is an FDA licensed facility that predominantly performs testing for the plasma industry. The laboratory is accredited by CAP, is regulated by several US and non-US governmental agencies, and holds licenses from NY and 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:
Leading regulatory strategy and managing all regulatory submissions including Biological License Applications for NGI's proprietary assay platform.
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.
Oversees the creation, execution, and maintenance of the quality management system policies and procedures.
Assists with identifying, remediating, and documenting quality issues per established protocols.
Oversees the internal audit program and participates as an auditor.
Responsible for continued effectiveness of the external audit program including review of findings and responses to agencies.
Prepares monthly reports for senior operations leadership for management reviews.
May include other duties as assigned by management
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 with 7-10 years of quality management experience in the pharmaceutical or medical device industry and 3-5 years supervisory experience
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) is part of the LabCorp Specialty Testing Group. We provide advanced genetic testing services for blood screening, medical testing, clinical research, and direct to consumers through approved partners. The company offers industry leading expertise in both low and high density molecular and genomic technologies and has a strong tradition of exceptional quality and s...cience. NGI has pioneered leading assays for human immunodeficiency virus (HIV), hepatitis A, B, and C (HAV, HBV, and HCV) viruses and other infectious agents including sensitive and high throughput methods for pooled specimen testing. NGI also offers production scale genome-wide and targeted genetic analysis services utilizing state of the art techniques. We are a licensed clinical laboratory by a number of state and federal agencies including CLIA and hold active Biologics Licenses from the US Food and Drug Administration (FDA). Lastly, NGI is a certified Clinical Genetic Molecular Biology Scientist (CGMBS) training site and we offer opportunities for California Laboratory Scientist licensure training for approved employees.