Acelpa Health · 1 day ago
Director of Quality & Compliance
United States
Full-time
Remote
Director/Executive
7+ years expAcelpa Health is a national platform that integrates trusted specialty infusion providers to offer an innovative care model. The Director of Quality & Compliance is responsible for establishing and maintaining a robust Quality Management Program and ensuring ongoing regulatory and accreditation compliance across the organization's specialty infusion pharmacy operations.
Health CareHealth DiagnosticsMedicalPharmaceuticalSoftware
Hiring Manager
Amanda Burand, PharmD, RPh, CSP
Responsibilities
Develop, implement, and maintain a comprehensive Quality Management Program consistent with CMS Home Infusion Therapy (HIT) requirements, ACHC/URAC/Joint Commission standards, and state pharmacy and home health regulations
Oversee continuous quality improvement (CQI/PI) activities, including identification of quality indicators, data collection, trending, root cause analysis, and corrective action plans
Lead Quality Committee activities, including preparation of agendas, dashboards, meeting minutes, and follow-up action tracking
Monitor patient outcomes, adverse events, medication errors, infections, and infusion-related complications, ensuring timely investigation and mitigation
Analyze healthcare regulatory requirements (HIPAA, FDA, CMS, OIG, state and federal pharmacy and nursing laws) and their impact on pharmacy and nursing operations
Ensure compliance with regulatory standards for compounding practices, including USP <797>, <800>, and state pharmacy laws
Collaborate with cross-functional teams to assess risks, identify gaps, and recommend compliance solutions
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
Monitor regulatory changes and provide recommendations for necessary business adjustments
Support data reporting, documentation, and compliance-related performance metrics
Lead initial and ongoing accreditation efforts (ACHC, URAC, Joint Commission, or other applicable bodies)
Maintain continuous survey readiness through internal audits, mock surveys, tracer activities, and staff education
Coordinate submission of accreditation applications, self-assessments, corrective action plans, and re-accreditation documentation
Oversee development, review, approval, and maintenance of organizational policies and procedures to ensure regulatory compliance, accreditation compliance and operational alignment
Ensure policies reflect current regulatory requirements and best practices for specialty pharmacy and home infusion services
Implement document control processes and ensure staff access to current versions
Qualification
Required
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)
Preferred
PharmD strongly preferred
Accreditation expertise with URAC and ACHC, including successful reaccreditation cycles, survey preparation, and standards implementation strongly preferred
Prior leadership experience in specialty pharmacy, specialty infusion pharmacy or home infusion pharmacy
Company
Acelpa Health
Acelpa Health connects specialty infusion pharmacies and providers to deliver coordinated therapies for complex conditions.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase