Sr. Manager, Pathology Quality, Safety & Regulatory Compliance

Overview

The Sr. Manager, Pathology Quality, Safety & Regulatory Compliance provides strategic leadership for the Anatomic Pathology Quality Management System and Patient Safety Program. This role is responsible for regulatory compliance, inspection readiness, patient safety event oversight, risk mitigation, quality performance monitoring, and governance across all pre-analytical, analytical, and post-analytical laboratory operations.

The position partners closely with the Anatomic Pathology Director, Medical Director of Quality and Patient Safety, and Senior Managers to ensure continuous regulatory compliance, operational excellence, and a culture of safety aligned with institutional and healthcare standards.

Key Responsibilities:

• Annual Quality & Safety Strategic Planning
  • Develop and implement the Annual Anatomic Pathology Quality & Safety Plan with measurable goals and performance benchmarks.
  • Align quality initiatives with institutional safety objectives and AP strategic priorities.
  • Provide structured quarterly governance updates to AP leadership.
• Regulatory Compliance & Inspection Readiness
  • Ensure ongoing compliance with CAP, CLIA, CMS, Joint Commission, State DPH, OSHA, and HIPAA standards.
  • Maintain a comprehensive inspection readiness calendar and coordinate mock audits.
  • Standardize regulatory documentation systems and corrective action tracking.
  • Escalate recurring or unresolved compliance risks to AP leadership.
• Corrective & Preventive Action (CAPA) Oversight
  • Lead Root Cause Analysis (RCA) and Apparent Cause Analysis (ACA) investigations.
  • Develop and oversee a structured Corrective and Preventive Action (CAPA) program.
  • Monitor implementation timelines and validate effectiveness of corrective actions.
• Internal Audit & Post-Analytical Monitoring
  • Develop and execute a structured internal audit program across all AP sections.
  • Conduct post-analytical quality reviews addressing report accuracy, amended reports, and documentation integrity.
  • Trend discrepancies and implement mitigation strategies.
• Hospital-Level Specimen Event Collaboration
  • Serve as the primary laboratory liaison for hospital-level specimen-related safety events.
  • Collaborate with Hospital Quality, Risk Management, and procedural areas to investigate specimen handling and chain-of-custody issues.
  • Develop and monitor corrective action plans with hospital stakeholders.
• High Reliability Organization (HRO) & Culture Development
  • Lead implementation of High Reliability Organization principles across AP operations.
  • Promote peer accountability and a just culture framework.
  • Develop mentorship and safety reinforcement initiatives.
• Laboratory Safety & Staff Compliance Program
  • Develop and oversee a comprehensive Laboratory Safety & Behavioral Compliance Program.
  • Standardize onboarding, safety, education and ongoing compliance training.
  • Conduct environmental and behavioral compliance audits.
• Daily Safety Huddles & Governance
  • Design and oversee structured Daily AP Section Safety Huddles.
  • Track issues raised during huddles and ensure timely follow-up and escalation.
  • Facilitate monthly department-wide safety governance meetings.
• Document Control & MediaLab Governance
  • Serve as departmental owner and administrator of MediaLab.
  • Oversee policy lifecycle management, revision cycles, and regulatory alignment audits.
• Operational Presence & Engagement
  • Maintain active on-site presence across AP sections to monitor safety and quality practices.
  • Conduct routine safety and compliance rounds.
• Legal & Billing Compliance Oversight
  • Provide oversight for laboratory-related legal requests in collaboration with institutional legal offices.
  • Collaborate with billing and revenue cycle teams to mitigate documentation and coding compliance risks.
• Supervisory Responsibilities
  • Direct and evaluate the performance of the QPS Coordinator.
  • Ensure operational continuity and defined escalation pathways.

Required Skills and Abilities

1. Minimum five years of progressive leadership experience in a clinical diagnostic or academic medical center setting.
2. Demonstrated expertise in laboratory operations, regulatory compliance, and quality management systems.
3. Experience leading regulatory inspections and healthcare quality initiatives.
4. Strong analytical, leadership, and communication skill.

Preferred Skills and Abilities

1. ASCP certification in an Anatomic Pathology discipline preferred.

Principal Responsibilities

1. Directs, monitors, and assesses needs and directs the application of resources of an administrative University office dealing with one or more major functional areas.
2. Directs and implements solutions to problems that are routine to complex in nature and that affect multiple functional areas of responsibility.
3. Plans and/or participates in planning University activities on a long-term basis to comply with University goals and objectives.
4. Establishes and implements consistent university-wide policies in multiple functional areas of responsibility.
5. Ensures that University office policies and procedures are in compliance with federal, state, and local laws and ordinances.
6. Develops and monitors goals and objectives for managerial and professional staff in compliance with University strategies.
7. Directs a staff of exempt and non-exempt employees.
8. May perform other duties as assigned.

Required Education and Experience

Bachelor’s Degree in related field and eight years of experience or an equivalent combination of education and related experience.