Advisor,Program Quality Assurance Job Lakeland area,Florida USA,Quality Assurance

Position:Advisor, Program Quality Assurance

Location: Hybrid, FL

Job :640

# of Openings:1

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 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

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, elevate, 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

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…

Advisor, Program Quality Assurance