Director, Quality - Specialty Pharmacy

Overview

The Director, Quality leads Orsini’s enterprise Quality Management Program for rare disease specialty pharmacy operations. This role develops and executes the annual Quality Plan; ensures compliance with accreditation standards (URAC, ACHC, NABP) and applicable regulations (HIPAA, FDA, DEA, State BOP); oversees internal and external audits, vendor quality, deviation/CAPA management, document control; and partners cross-functionally to improve patient safety, clinical effectiveness, and operational excellence.

The Director advances a culture of continuous improvement through data-driven insights, risk mitigation, and transparent reporting to senior leadership.

Own the Quality Management System (QMS), including policies, SOPs, work instructions, forms, and quality records. Ensure timely document lifecycle management (draft, review, approval, training, archival) and maintain accreditation readiness. Lead Quality Management Committee (QMC) governance and quarterly reporting.

Maintain full compliance with URAC, ACHC, and NABP standards. Lead re-accreditation cycles, readiness assessments, gap remediation, and evidence documentation.

Plan and execute internal audits and vendor audits; coordinate client audits and regulatory inspections. Track findings, risk-rank issues, manage corrective and preventive actions (CAPA), and verify effectiveness. Report audit outcomes, trends, and closure timeliness to senior leadership.

Oversee deviation/incident management, root cause analysis, CAPA development, and change control. Analyze trends, implement preventive measures, and communicate lessons learned across teams to reduce repeat events.

Oversight of the vendor qualification and monitoring program for specialty distribution, cold chain logistics, and service providers. Maintain quality agreements, scorecards, audits, and CAPA for vendors. Collaborate with Supply Chain to mitigate risk and improve performance.

Manage and develop quality staff; set goals, coach performance, support career development, and foster engagement. Ensure staffing and succession planning for critical quality functions.

Lead cross-functional initiatives to improve patient safety, data integrity, dispensing accuracy, cold-chain reliability, and patient experience. Utilize Lean/Six Sigma tools, statistical analysis, and dashboards to prioritize and track improvements.