Regulatory, Credentialing & Quality Director

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profile Job Location:

Louisville, KY - USA

profile Monthly Salary: USD 160000 - 160000
Posted on: 5 hours ago
Vacancies: 1 Vacancy

Job Summary

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

Essential Responsibilities/Duties:

Regulatory & Compliance Leadership

  • 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.
Credentialing & Competency Oversight
  • 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.
Quality Management & Performance Improvement
  • Lead the organizations 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.

Audit Investigation & CAPA

  • 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.
Leadership Training & Culture
  • 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.

Reporting & Governance

  • Prepare and present reports to executive leadership.
  • Escalate risks appropriately and recommend mitigation strategies.
  • Support strategic planning with data-driven quality and compliance insights.


Qualifications:
Education
Bachelors degree in a relevant field; Healthcare Administration Business Life
Sciences Biological Chemical or Clinical Sciences field Quality Management Public
Health or Regulatory Affairs.
Masters degree (MBA MHA MPH MS in Regulatory Affairs or Quality)
Competencies/Skills
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
Experience
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
Certifications/Licenses
ASCP or applicable Quality licensure (ASQ Six Sigma etc.) preferred


Benefits

Relocation assistance offered


Required Skills:

Essential Responsibilities/Duties: Regulatory & Compliance Leadership 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. Credentialing & Competency Oversight 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. Quality Management & Performance Improvement Lead the organizations 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. Audit Investigation & CAPA 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. Leadership Training & Culture 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. Reporting & Governance Prepare and present reports to executive leadership. Escalate risks appropriately and recommend mitigation strategies. Support strategic planning with data-driven quality and compliance insights. Qualifications: Education Bachelors degree in a relevant field; Healthcare Administration Business Life Sciences Biological Chemical or Clinical Sciences field Quality Management Public Health or Regulatory Affairs. Masters degree (MBA MHA MPH MS in Regulatory Affairs or Quality) Competencies/Skills 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 Experience 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 Certifications/Licenses ASCP or applicable Quality licensure (ASQ Six Sigma etc.) preferred


Required Education:

Bachelors degree in a relevant field; Healthcare Administration Business Life Sciences Biological Chemical or Clinical Sciences field Quality Management Public Health or Regulatory Affairs. Masters degree (MBA MHA MPH MS in Regulatory Affairs or Quality)

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 ...
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Company Industry

IT Services and IT Consulting

Key Skills

  • Quality Assurance
  • FDA Regulations
  • ISO 9001
  • Root cause Analysis
  • Biotechnology
  • Clinical Trials
  • Quality Systems
  • Food Processing
  • Quality Control
  • Quality Management
  • cGMP
  • HACCP