Regulatory, Credentialing & Quality Director

Shyft6•Louisville, KY

About The Position

The Regulatory, Credentialing & Quality Director is responsible for leading and integrating regulatory compliance, credentialing oversight, and quality management across the organization. This role ensures adherence to all applicable federal, state, accrediting, and professional standards while driving a culture of continuous improvement, patient safety, and operational excellence. This role leads quality assurance, training development, document control, and regulatory reporting across operations, supporting patient safety, data integrity, and organizational readiness for audits and inspections as defined by CAP, CLIA, and OSHA. The Director serves as a key advisor to executive leadership, laboratory leadership, and clinical teams, translating regulatory requirements into effective systems, policies, and practices.

Requirements

Bachelor’s degree in a relevant field; Healthcare Administration, Business, Life Sciences, Biological, Chemical, or Clinical Sciences field, Quality Management, Public Health, or Regulatory Affairs.
Master’s degree (MBA, MHA, MPH, MS in Regulatory Affairs or Quality)
Excellent verbal and written communication skills
Ability to communicate effectively with various level stakeholders, including Executive Management
Ability to travel about 20% of time
Ability to multi-task and manage multiple concurrent projects at a departmental level
Leadership experience in regulatory affairs, healthcare credentialing, quality assurance, compliance, or related functions.
Proven record of managing cross-functional teams and leading complex organizational processes.
Experience with audits, surveys, and regulatory inspections at state/federal levels

Nice To Haves

ASCP or applicable Quality licensure (ASQ, Six Sigma, etc.) preferred

Responsibilities

Ensure organizational compliance with applicable regulatory and accrediting bodies (e.g., CLIA, CAP, CMS, state agencies).
Lead regulatory readiness activities, including inspections, surveys, audits, and follow-up actions.
Interpret regulatory requirements and translate them into policies, procedures, and operational controls. Monitor regulatory changes and proactively assess organizational impact.
Serve as primary liaison with regulatory agencies and accrediting organizations.
Oversee credentialing, licensure, certification, and recredentialing processes for applicable personnel.
Ensure systems are in place to track expirations, renewals, and compliance with scope-of-practice requirements.
Support competency assessment programs aligned with regulatory and accreditation standards.
Lead the organization’s Quality Management System (QMS).
Oversee incident management, nonconformance reporting, CAPA, and root cause analysis activities.
Establish quality metrics, dashboards, and reporting structures.
Lead or support process improvement initiatives to reduce risk, improve outcomes, and prevent recurrence of failures.
Direct internal audits and risk assessments.
Lead investigations of significant events, near misses, and mass failures.
Ensure timely, effective corrective and preventive actions.
Track NCE/CAPA effectiveness and sustainability.
Provide training and guidance to leaders and staff on regulatory, credentialing, and quality expectations.
Partner with operational leaders to embed quality and compliance into daily workflows.
Mentor and develop quality and compliance staff; oversee training content development, delivery, effectiveness assessment, and documentation.
Prepare and present reports to executive leadership.
Escalate risks appropriately and recommend mitigation strategies.
Support strategic planning with data-driven quality and compliance insights.