PHARMACY QUALITY AND COMPLIANCE SPECIALIST

The Pharmacy Quality and Compliance Specialist collaboratively develops, implements, and monitors quality and process improvement (PI) initiatives to ensure compliance, quality, and safety in pharmacy and medication-use areas with oversight by pharmacy. Additionally, they are responsible for continuous regulatory or accreditation readiness by ensuring pharmacy processes and staff are in compliance with all necessary standards. In collaboration with leadership, this position manages multiple end-to-end projects through the entire life cycle and provides regular updates to key stakeholders. Finally, the position collaboratively develops, documents, and maintains the appropriate education and training required for any quality/process improvement initiative(s) and any regulatory or accreditation standards. Essential Job Functions • In collaboration with leadership, manage multiple end-to-end projects through the entire life cycle (definition, initiation, planning, execution, and closure) and provide regular updates to key stakeholders. Establish timeframes for meeting goals and conduct analysis if goals are not within designated timeframe. • Manages/assists with any compliance database system, including training, updates, security management, report generation, etc. Provide guidance to staff and leadership on quality and process improvement initiatives and assist with setting priorities and timelines for the projects. • Performs as a team facilitator and driver of change for projects as assigned. • Develops, implements and maintains tracer program to ensure medication process expectations are being met throughout organization (ie. Med storage audit) Perform regular and one-time audits and communicate findings and areas of non-compliance to leadership. Coordinates efforts for self and on-site inspections. • Collaborates with pharmacy leadership to help organize and project manage goals related to strategic plan of department • Oversee the revision, development, and retirement of organizational and departmental pharmacy policies, protocols and standing orders • Maintain document control for department in accordance with ISO9001 standards including organizing all regulatory documentation • Identification, tracking, and trending of QI/PI measures and maintain in a control phase. Prepare reports, dashboards, or presentations for leadership and oversight bodies based on time-specific requirements. • Ensure continual readiness and compliance with accreditation and regulatory standards related to pharmacy services and the medication-use process. In collaboration with pharmacy leadership, responsible for the development and implementation of the strategic plan for medication-use regulatory and accreditation oversight. • Provide standard interpretation and compliance monitoring for department for DNV/ISO 9001, CMS and other regulatory and accrediting bodies that the pharmacy department must comply with. Assists in DNV, CMS, BOP, and other survey preparation, identifying activities and personnel accountable for preparation activities. • Monitors updates to regulatory and accreditation standards and performs gap analysis to determine how to bring department into compliance. Serves as the accreditation and regulatory liaison and central point-of-contact. Manages required accreditation and regulatory activities (e.g., application(s), internal scoring of standards, reporting, gap analysis, scheduling inspections). • Reviews all publications from regulatory bodies and accrediting organizations and communicates changes required to maintain compliance. • Work with content experts to document, and maintain the appropriate education and competency required for any quality/process improvement initiative(s) and any regulatory or accreditation standards.