Director, Quality - Specialty Pharmacy

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.

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. 

ESSENTIAL 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.

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. 

Disclaimer: The information written in this job description indicates the general nature and level of work to be performed. This job description is not designed to contain or be interpreted as totally comprehensive of every job duty, responsibility, or qualification required by an employee assigned to this job. While employed in this position, an employee may be required to perform other assignments not listed in this job description.

EXPERIENCE & EDUCATION

• 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.
• Certifications & Training (preferred): CQIA/CQA, Six Sigma/Lean, CPPS (patient safety)

KNOWLEDGE

• 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. 

SKILLS

• Expert knowledge of quality systems, accreditation standards, and audit methodologies.
• Strong analytical skills: root cause analysis, risk assessment (FEMA), and 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.

EMPLOYEE BENEFITS

• Medical Coverage, Dental, and Vision Coverage
• 401(k) with employer match
• Accident and Critical Illness coverage
• Company-paid life insurance options
• Generous PTO, paid holidays, and floating holidays
• Tuition reimbursement program.

Equal Employment Opportunity

Orsini Rare Disease Pharmacy Solutions is committed to the principle of Equal Employment Opportunity for all employees and applicants. It is our policy to ensure that both current and prospective employees are afforded equal employment opportunity without consideration of race, religious creed, color, national origin, nationality, ancestry, age, sex, marital status, sexual orientation, or present or past disability (unless the nature and extent of the disability precludes performance of the essential functions of the job with or without a reasonable accommodation) in accordance with local, state and federal laws.

Americans with Disabilities Act

Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law.