Manger, Transplant Quality & Regulatory Compliance

Beth Israel Lahey Health•Boston, MA

19d•Onsite

About The Position

In this role, the Manager, Transplant QAPI & Regulatory Compliance provides leadership for transplant quality assessment, performance improvement, patient safety, and regulatory compliance across hospital solid organ transplant programs. Reporting to the Director of the Transplant Institute, this role oversees the design and execution of a comprehensive, data-driven QAPI program to ensure sustained compliance with CMS Conditions of Participation, OPTN requirements, and other applicable regulatory standards. This position serves as the hospital’s subject-matter expert in transplant quality and regulatory affairs.

Requirements

Bachelor’s degree required
Minimum of 5 years of progressive experience in transplant quality, regulatory compliance, or performance improvement within an academic medical center or transplant program.
Demonstrated expertise in CMS Conditions of Participation and OPTN regulatory requirements.
Proficiency in written and verbal English communication.

Nice To Haves

Master’s degree in healthcare administration, healthcare informatics, public health, or related field preferred.
Professional certification in quality (CPHQ), patient safety, or healthcare compliance preferred.

Responsibilities

Leads the development, implementation, and oversight of the integrated Quality Assessment and Performance Improvement (QAPI) program across hospital solid organ transplant programs.
Ensures continuous compliance with CMS Conditions of Participation, OPTN policies, HRSA requirements, and applicable state regulations.
Maintains ongoing survey readiness and leads preparation for CMS certification, re-certification, and focused or unannounced regulatory surveys.
Oversees investigation, documentation, and resolution of transplant-related adverse events, near misses, and patient safety concerns.
Analyzes transplant outcomes and operational performance data to identify trends, risks, and improvement opportunities.
Develops, monitors, and sustains corrective action plans to address quality or regulatory findings.
Ensures accuracy, integrity, and timeliness of transplant quality data, regulatory submissions, and internal and external reporting.
Prepares and presents quality, safety, and regulatory reports to transplant leadership and governance committees.
Serves as a strategic advisor to transplant clinical and administrative leadership on quality, safety, and regulatory risk.
Supports onboarding, certification, and quality infrastructure development for new or expanding hospital transplant programs and services.