Director, Quality - Specialty Pharmacy
Elk Grove Village, Cook County, Illinois, 60009, USA
Listed on 2026-01-02
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Healthcare
Healthcare Management
Careers with real impact.
Every role at Orsini moves a patient closer to life-changing therapy. We partner with biopharma innovators, healthcare providers, and payers to make access simple, compassionate, and reliable - so no patient is left behind. Make your next role matter.
ABOUT ORSINIProviding compassionate care since 1987, Orsini is a leader in rare disease and gene therapy pharmacy solutions, built to simplify how patients connect to advanced medicines. Through our comprehensive commercialization solutions including a nationwide specialty pharmacy, patient services hub, home infusion and nursing network, and third-party logistics provider, we work with biopharma, providers, and payors to ensure LIVE IT Core Values
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Orsini is on a mission to be the essential partner for biopharma innovators, healthcare providers, and payers to support patients and their families in accessing revolutionary treatments for rare diseases. Through our integrated portfolio of services, we seek to pioneer comprehensive solutions that simplify how patients connect to advanced therapies while providing holistic, compassionate care so that No Patient is Left Behind™.
COREVALUES
At the heart of our company culture, the Orsini LIVE IT Core Values serve as guiding principles that shape how we interact with each other and those we serve. These values are the driving force behind our commitment to excellence, collaboration, and genuine care in every aspect of our work.
COMPENSATION & LOCATIONThe salary range for this role is $130,000-$140,000, compensation will be determined based on a combination of factors, including skills, experience, and qualifications.
This remote position within the United States and may involve overnight travel for customer and internal meetings.
POSITION SUMMARYThe 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.
JOB DUTIES:
Quality System 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 NAPB 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 preventitive actions (CAPA), and verify effectiveness.
- Report audit outcomes, trends, and closure timelines to senior leadership.
- Oversee deviation/incident management, root cause analysis, CAPA development, and change control.
- Analyze trends, implement preventitive 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 functions.
- Lead cross-functional initiatives…
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