Director of Quality and Compliance

The Director of Quality & Compliance is a key leadership role responsible for establishing, leading, and maintaining a robust Quality Management Program (QMP) and ensuring ongoing regulatory and accreditation compliance across our national specialty infusion pharmacy operations. This role will oversee quality improvement initiatives, compliance programs, accreditation readiness, audit management, policy development, and risk mitigation strategies to support safe, effective, and compliant patient care.

The ideal candidate is a strategic, detail-oriented healthcare professional with deep knowledge of specialty infusion pharmacy requirements, industry best practices, and regulatory standards at the federal, state, and accreditation levels.

Reporting Relationship

Reports to Chief Compliance Officer

Responsibilities include the following:

1. Analyze healthcare regulatory requirements (HIPAA, FDA, CMS, OIG, state and federal pharmacy and nursing laws) and their impact on pharmacy and nursing operations.
2. Ensure compliance with regulatory standards for compounding practices, including USP <797>, <800>, and state pharmacy laws.
3. Support the development, implementation, execution and monitoring of compliance programs, policies, and procedures.
4. Collaborate with cross-functional teams to assess risks, identify gaps, and recommend compliance solutions.
5. Conduct audits, risk assessments, and process reviews to ensure adherence to compliance and accreditation standards (URAC & ACHC). Identifies corrective action plans and provides guidance to prevent future issues.
6. Assist in developing training materials and compliance education programs to promote an understanding of key compliance principles and their importance to the success of the organization.
7. Monitor regulatory changes and provide recommendations for necessary business adjustments.
8. Support data reporting, documentation, and compliance-related performance metrics.
9. Assist in the implementation of healthcare technology solutions that support compliance efforts.
10. Liaise with internal and external stakeholders, including auditors and regulatory agencies.
11. Contribute to process improvement initiatives to enhance operational efficiencies and compliance effectiveness.
12. Maintains and revises policies and procedures for the general operation of the Compliance Program, company operations and its related activities to prevent illegal, unethical, or improper conduct.
13. Manages day-to-day operation of the Compliance Program.

Minimum Qualifications

• Bachelor’s degree in Pharmacy, Healthcare Administration, Nursing, or a related healthcare field.
• 7–10+ years of progressive experience in healthcare quality, regulatory compliance, or pharmacy operations, preferably within specialty infusion, home infusion, or specialty pharmacy settings.
• Robust experience developing, implementing, and managing Quality Management Systems (QMS), including CAPA processes, internal audits, process improvement initiatives, and quality performance monitoring.
• Strong understanding of quality frameworks and methodologies (e.g., root cause analysis, risk assessment, quality indicators, continuous quality improvement).
• Hands-on experience interpreting and applying regulatory standards from state Boards of Pharmacy, CMS, FDA, HIPAA, and related healthcare regulations.
• Demonstrated ability to prepare for, lead, and respond to internal and external audits.
• Proven leadership experience managing quality, compliance, or regulatory teams in a multi-site or national environment.
• Exceptional analytical skills with the ability to evaluate trends, identify risks, and develop data-driven improvement strategies.
• Strong communication skills with the ability to educate staff, collaborate cross-functionally, and influence organizational leaders.
• Exhibits strong leadership skills, outstanding interpersonal skills, a collaborative style, and a reputation for successfully working across departmental lines to implement new policies, procedures, and programs.
• Demonstrated independence and flexibility, with the ability to enforce organization policies and to lead through guidance.
• Demonstrated ability to manage multiple priorities and deadlines.
• Willingness to travel (up to 25% travel).