Willow Grove, PA - Sr. Director of Quality Assurance
We seek a Senior Director of Quality Assurance responsible for the overall operation of the Quality Assurance department and directing the Quality Assurance staff. This individual leads and ensures compliance with all laboratory-based regulatory needs of the business, including maintenance of licensures and accreditations, internal quality assurance policies, programs and procedures, and appropriate staffing. These duties are not confined to the laboratory, but include all aspects of business operations, including IT, Finance, Sales, Marketing and others. Additionally, this individual will lead quality management improvements, specifically utilizing LEAN and related management tools. The successful candidate serves as part of the senior management team .
Candidates must have a PhD in Clinical Chemistry or other applied laboratory science plus 10 or more years laboratory based quality assurance experience. In addition, candidates will have the following:
Extensive experience in laboratory regulatory compliance and knowledge of laboratory regulations associated with CLIA, ISO 15189, New York State, CAP, ABFT and others.
Strong background in laboratory quality assurance, including standard operating procedures and laboratory-based statistics.
Knowledge of CLSI, ABFT, CAP requirements for laboratory processes and accreditation.
Applied knowledge in QMS and continuous quality improvement programs such as ISO, Six Sigma, and LEAN.
Applied knowledge of analytical method validation, establishing reference intervals and implementing quality control procedures associated with clinical laboratory testing, including statistical analysis of data.
Familiarity with FDA oversight of laboratory developed tests (LDTs).
Ability to understand and work with laboratory operations for purposes of integrating quality assurance improvements, including training of staff.
Applied understanding of CAPA programs and their application to laboratory performance gaps and improvements.
Strong communication skills with an ability to work cross-departmentally to facilitate continuous quality change to ensure outstanding laboratory performance and delivery of service.
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