Director, Quality - Specialty Pharmacy

Orsini Healthcare•Elk Grove Village, IL

3d•$130,000 - $140,000•Remote

About The Position

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 ORSINI Providing 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 No Patient is Left Behind™ OUR MISSION 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™. CORE VALUES 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 & LOCATION The 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 SUMMARY 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.

Requirements

5+ years of quality assurance experience in specialty pharmacy or healthcare, with at least 3+ years in management capacity.
Accreditation (URAC/ACHC) experience required; cold-chain and REMS program exposure preferred.
Bachelor's degree in business, Healthcare, Pharmacy, or related, required; PharmD/advanced degree preferred.
Expert knowledge of quality systems, accreditation standards, and audit methodologies.
Strong analytical skills: root cause analysis, risk assessment (FMEA), statistical trending.
Outstanding written/verbal communication; executive reporting and presentations.
Ability to lead cross-functional teams, influence without authority, and manage change.
Proficiency with QMS platforms, document control, learning management systems (LMS), and dashboard tools.
Demonstrated commitment to patient safety, data integrity, and continuous improvement.

Nice To Haves

PharmD/advanced degree preferred.
Certifications & Training (preferred): CQIA/CQA, Six Sigma/Lean, CPPS (patient safety)
cold-chain and REMS program exposure preferred.

Responsibilities

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.
Accreditation & Regulatory Compliance Maintain full compliance with URAC, ACHC, and NAPB standards. Lead re-accreditation cycles, readiness assessments, gap remediation, and evidence documentation.
Audit & Inspection Management 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.
Deviation, CAPA & Change Control 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.
Vendor Quality Oversight 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.
People Leadership & Development Manage and develop quality staff; set goals, coach performance, support career development, and foster engagement. Ensure staffing and succession planning for critical functions.
Strategic Projects & Continuous Improvement Lead cross-functional initiatives to improve patient safety, data integrity, dispensing accuracy, cold-chain reliability, and patient experience. Utilize Lead/Six Sigma tools, statistical analysis, and dashboards to prioritize and track improvements.
Collaboration & Key Stakeholders Works closely with Pharmacy Operations, Clinical Services (nursing, pharmacists), Patient Services, Compliance/Privacy, IT/Data & Analytics, Supply Chain/Logistics, Client Services, and Finance. Interfaces with accreditation bodies, auditors, payers, manufacturers (including REMS programs), and key vendor.