Director, Lab Quality & Compliance

About This Role

This role involves planning and directing day-to-day activities related to regulatory compliance, quality, safety, and performance improvement initiatives within Mass General Brigham's laboratory services. The Director ensures JCAHO and CAP compliance, manages professional staff competency reviews, and oversees quality incentive programs.

Responsibilities

• Plan and direct day-to-day activities related to regulatory compliance, quality, safety, and performance improvement initiatives in laboratory services.
• Ensure JCAHO and CAP compliance and inspection readiness.
• Coordinate professional staff competency review, development, and monitoring of KPIs for the system.
• Coordinate PO quality incentive programs, identifying and directing performance improvement projects.
• Follow-up and resolve safety reports.
• Maintain the Pathology quality management program.
• Direct the development and implementation of quality, safety, and compliance training programs for Pathology staff.
• Monitor department or laboratory performance for key operational procedures and identify areas for improvement.
• Identify deficiencies and collaborate with hospital or department personnel to develop and implement corrective action plans.
• Direct laboratory accreditation/inspection preparation, including education and periodic performance review evaluations.
• Manage all CLIA certificate applications and documentation, including Point of Care sites.

Requirements

• Bachelor's Degree in Clinical Laboratory Sciences
• Medical Laboratory Scientist (MLS Certification)
• 8-10+ years experience in Pathology Quality and Compliance
• 3-5 years experience supporting regulatory inspections
• Extensive knowledge of laboratory systems and technical knowledge related to quality management and complex laboratory regulatory requirements.

Qualifications

• Bachelor's Degree Clinical Laboratory Sciences required or Bachelor's Degree Administration preferred
• 8-10+ years of experience in Pathology Quality and Compliance and 3-5 years supporting regulatory inspections.

Benefits

Certifications