St. Jude has an exciting opportunity in the Department of Pathology for a Director-Laboratory Quality and Compliance to lead the only CAP 15189 accredited pediatric hospital laboratory currently in North America. This position will be a key member of Pathology’s leadership team who will be responsible for the strategic direction for the quality, regulatory, accreditation and compliance activities across the department. The selected individual will need to be a change agent and look for creative and innovative ways to continually improve how quality is integrated in the day-to-day operations in Pathology. To be successful in this role, you will need to be able to communicate effectively, build collaborative relationships with medical, scientific and operational leaders, be a problem solver, have focus and great attention to detail, and be a change agent to support operational excellence.
Responsibilities
Develops, organizes and directs activities of the Quality Program
Manages the daily work of quality personnel which consists of 6 currently
Ensures compliance with applicable federal, state and local laws or regulations pertaining to Pathology and Clinical Lab operations
Oversee and develop programs to ensure compliance with all regulatory activities to include CLIA and FDA (Blood Bank, Blood Donor, Blood Product Manufacturing) and all accreditation activities in Pathology to include CAP Lab Accreditation, CAP15189 Accreditation, CAP Biorepository Accreditation, AABB, ASHI and FACT collection facility requirements
Direct the processes to review and analyze quality data and other analytics for data presentation and reports that will be used for continual improvement
Serve as a key operational leader in Pathology and will perform special projects as assigned
Minimum Education
Bachelor's degree in quality, medical laboratory science, science, business or related field required
Master's degree is strongly preferred
Minimum Experience
Ten (10) years of quality management and leadership experience is required. Quality experience obtained in a clinical laboratory management role will count toward experience requirements
Experience with implementing and maintaining Lean/Six Sigma improvements is required
Experience with clinical laboratory quality is highly desired
Required Credentials
Other Credentials
Certification by the American Society for Quality as a Certified Manager of Quality & Organizational Excellence (CMQ/OE) required within 18 months of hire
