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AI Summary
Leads pharmacy program quality assurance, compliance monitoring, and continuous improvement initiatives to ensure patient safety and operational excellence. Manages quality documentation, audit readiness, and CAPA processes while developing performance dashboards for stakeholders.
Summary
The Advisor, Program Quality Assurance leads pharma program quality assurance, continuous quality improvement, compliance monitoring, audit readiness, quality documentation, reporting and deliverables as stated in the contract. This role ensures pharmacy quality activities are accurate, current, audit-ready, and aligned with client requirements.
The Advisor, Program Quality Assurance leads pharma program quality assurance, continuous quality improvement, compliance monitoring, audit readiness, quality documentation, reporting and deliverables as stated in the contract. This role ensures pharmacy quality activities are accurate, current, audit-ready, and aligned with client requirements.
The position partners with operations, clinical, compliance, analytics, IT, account management, Quality, and leadership teams to support patient safety, operational excellence, and continuous improvement across designated pharmacy program.
Essential Duties and Responsibilities
Quality Assurance and Continuous Quality Improvement
Quality Assurance and Continuous Quality Improvement
- Lead pharmacy quality assurance and continuous quality improvement for pharma program.
- Audit and ensure maintenance of pharmacy quality standards, policies, procedures, documentation, and compliance protocols.
- Analyze quality metrics, operational trends, to identify improvement opportunities.
- Partner with cross-functional teams to improve workflows, strengthen quality outcomes, and support client deliverables.
- Support strategic quality initiatives that promote compliance, patient safety, and operational excellence.
Quality Documentation and Audit Readiness
- Maintain oversight of quality documentation, including policies, workflows, audit records, CAPAs, compliance documentation, and quality records.
- Ensure documentation is accurate, complete, controlled, current, audit-ready, and aligned with applicable requirements.
- Lead audit readiness, client audit support, and related remediation activities.
- Ensure appropriate documentation, reporting, retention, and evidence management for quality and compliance activities.
Operations End to End
- Support implementation of programs, technologies, workflows, and operational initiatives from a quality and compliance perspective.
- Identify, escalate, and support mitigation of quality, compliance, documentation, and operational risks.
Quality Investigations, CAPA, and Risk Mitigation
- Manage quality investigations, root cause analyses, CAPAs, remediation activities, and risk mitigation efforts.
- Monitor CAPA effectiveness, closure timeliness, recurring issue trends, and sustainability of improvements.
- Use audit findings, quality trends, incident data, and operational observations to support proactive risk identification and improvement.
Adverse Event and Product Complaint Quality Oversight
- Monitor related documentation, audit findings, trends, escalations, and improvement opportunities.
- Partner with the Director of Designated Pharmacy Program, program and operational leaders to ensure AE and PC reporting expectations are documented, monitored, and remediated as needed.
Performance Reporting and Quality Metrics
- Develop and maintain quality dashboards, KPI reporting, executive summaries, scorecards, and program-level quality reports.
- Monitor operational quality metrics, audit results, CAPA trends, and compliance performance.
- Monitor and track end to end pharma program deliverables.
- Validate reporting with account management, operations, analytics, and leadership to support client deliverables and data accuracy.
- Present quality trends, risks, improvement opportunities, and performance summaries to key stakeholders.
Leadership, Training, and Cross-Functional Collaboration
- Lead, mentor, coach, and train quality assurance staff and operational teams.
- Promote a culture of quality, accountability, compliance, continuous improvement, and patient safety.
- Serve as a quality subject matter expert and strategic partner to cross-functional teams.
- Support change management, program implementation, workflow optimization, and quality governance activities.
Required Qualifications
- Experience in healthcare or quality management, or related field required; advanced degree preferred.
- Minimum of five years of experience in pharmacy operations or quality assurance, or healthcare operations, or another regulated environment.
- Leadership experience managing quality programs, audit readiness, documentation, investigations, CAPA, or continuous improvement initiatives.
Preferred Qualifications
- Certification in quality, compliance, risk management, healthcare quality, pharmacy, or auditing preferred.
- Experience with quality management systems, document control tools, audit management tools, analytics dashboards, and performance reporting systems.
- Experience in mail order pharmacy, specialty pharmacy, PBM operations, pharmacovigilance support, medication safety, accreditation, or client-facing pharmacy programs preferred.
- Experience with data analytics and process mapping.
Knowledge, Skills, and Abilities
- Strong knowledge of pharmacy quality assurance, continuous improvement, compliance monitoring, audit readiness, and documentation control.
- Ability to analyze data, metrics, audit findings, and operational trends to identify risks and improvement opportunities.
- Strong understanding of root cause analysis, CAPA, investigations, risk mitigation, and process improvement methods.
- Excellent communication skills, including preparation of executive summaries, quality reports, dashboards, and stakeholder communications.
- Ability to lead cross-functional initiatives and manage competing priorities in a regulated, metric-driven environment.
Work Environment / Physical Demands
This position is in a typical office environment which requires prolonged sitting in front of a computer. Requires hand-eye coordination and manual dexterity sufficient to operate standard office equipment including operation of standard computer and phone equipment. May have occasional high stress when dealing with customers/clients. Some travel may be required.
This position is in a typical office environment which requires prolonged sitting in front of a computer. Requires hand-eye coordination and manual dexterity sufficient to operate standard office equipment including operation of standard computer and phone equipment. May have occasional high stress when dealing with customers/clients. Some travel may be required.
EOE M/F/D/V – WellDyne and HealthDyne are equal opportunity employer and prohibits discrimination of any kind. All employment decisions are based on business needs, job
requirements, and individual qualifications, without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, veteran or disability status, or any other protected status under federal, state, or local law.
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