Compliance Manager

Job Description

Job Description

The Compliance Manager and Quality Management/Performance Improvement Coordinator is responsible for designing, implementing, and maintaining Carepoint Pharmacy’s regulatory compliance and accreditation readiness programs, and for coordinating the Quality Assurance/Performance Improvement (QA/PI) program across pharmacy operations. This role monitors and interprets applicable federal and state pharmacy laws and regulations, supports multi-state licensure and operational compliance, maintains a constant state of survey readiness, and ensures that policies, procedures, training, and performance monitoring meet current accreditation and industry standards applicable to Carepoint’s services.

Essential Duties and Responsibilities

• Serve as the primary point of coordination for regulatory compliance management, including monitoring, interpreting, and communicating applicable federal requirements and state pharmacy laws/regulations affecting Carepoint operations (dispensing, shipping, billing practices within scope, privacy/security, and compounding where applicable).
• Lead accreditation readiness activities for Carepoint’s applicable programs (e.g., URAC Mail Service Pharmacy, ACHC DMEPOS, ACHC MORX, and NABP Digital Pharmacy), including standards tracking, gap assessments, corrective action plans, evidence collection, and survey preparation.
• Coordinate the QA/PI program structure and documentation, including data collection and analysis, performance metric reporting, trending, and follow-up on identified opportunities for improvement.
• Coordinate and support the Quality Management/Performance Improvement (QA/PI) Committee, including agenda development, meeting scheduling, minutes, action item tracking, and evidence retention.
• Serve as the designated PI Coordinator; support development, implementation, and maintenance of the PI Plan; coordinate PI data collection, analysis, and trending; track PI goals and client/patient out-comes; and report PI activities, results, corrective actions, and effectiveness monitoring to leadership and the QA/PI Committee.
• Oversee the Organization’s complaint and grievance monitoring process from a quality and compliance perspective, including tracking/trending, root cause analysis where indicated, and escalating systemic issues through QA/PI and leadership channels.
• Develop, maintain, and control the policy and procedure lifecycle (creation, review cadence, approval routing, version control, distribution, and archival) in alignment with document control expectations and operational needs.
• Develop and deliver compliance and quality training content; coordinate initial orientation and ongoing training refreshers; and maintain auditable records of training completion and competency validation as required.
• Support personnel credential and licensure verification processes for staff and other applicable credentialed roles and coordinate remediation for expirations or compliance gaps in collaboration with People & Culture (HR) and leadership.
• Partner with operational leaders to conduct periodic internal audits/self-assessments, assess risk, and implement preventive controls (including CAPA development, implementation, effectiveness checks, and sustained monitoring).
• Maintain readiness documentation, including program plans, logs, committee records, audit tools, and supporting evidence required for onsite or virtual surveys and regulatory inspections.
• Support public-facing compliance accuracy by reviewing materials within the role’s scope (e.g., patient rights materials, complaint/grievance information, and quality-related disclosures) for alignment with policy and standards.
• Escalate high-risk issues promptly to the CEO/Owner/PIC and appropriate leadership, including events that may affect patient safety, regulatory compliance, licensure, accreditation status, or business continuity.
• Qualifications (Minimum)
  • Bachelor of Science in Pharmacy (BS Pharm) or Doctor of Pharmacy (PharmD) from an accredited college/school of pharmacy.
  • Active, unrestricted Illinois pharmacist license in good standing (additional licenses are a plus but not required unless assigned).
  • 3+ years of progressive experience in pharmacy compliance, quality management, accreditation preparation, or regulatory affairs (mail service, specialty, or similar complex pharmacy operations preferred).
  • Demonstrated working knowledge of pharmacy regulatory requirements and the practical implementation of accreditation standards in policy, training, and operational workflows.
  • Proficiency with pharmacy systems and documentation workflows (e.g., pharmacy management systems, document control, and common data/reporting tools).
  • Strong technical writing skills and the ability to produce concise, audit-ready policies, logs, and commit-tee documentation.
  • Ability to analyze data, identify trends, perform root cause analysis, and develop actionable CAPAs.
• Preferred Qualifications
  • Experience serving as accreditation lead/coordinator for URAC, ACHC, NABP, or similar pharmacy accreditation programs.
  • Experience coordinating a formal QA/PI program and supporting a quality committee structure (agenda, minutes, action tracking, and reporting).
  • Formal training in quality improvement methodologies (e.g., Lean, Six Sigma) or compliance program management.