Associate Director Quality & Compliance Operations - Remote

Description

About Orsini Rare Disease Pharmacy Solutions 

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™.  

LIVE IT 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.  

Leading Quality, Integrity, Valued Partner, Empathy, Innovation, Team-First

Salary Range: $100K-$150K

POSITION SUMMARY
The Assoc Director Quality & Compliance Operations will be responsible for supporting the quality management systems at Orsini, including pharmacy and 3PL license management, payor credentialing, internal and external audit, document control, and deviation and CAPA management. The Assoc Director Quality & Compliance operations will facilitate and coordinate quality activities as needed to ensure the provision of optimal pharmaceutical care to patients and clients of Orsini Healthcare and ensure compliance with all applicable regulatory and accreditation standards. This role involves periodic travel to partner sites, conferences, or corporate meetings.

REQUIRED KNOWLEDGE, SKILLS & TRAINING

• Bachelor’s degree or equivalent combination of education and experience required.
• Strong computer skills – Microsoft Excel, Word, PowerPoint, and Visio.
• Excellent interpersonal, written and verbal communication skills.
• Previous quality management experience preferred.
• Ability to identify, analyze, and solve complex problems.
• Ability to aggregate, analyze and make inferences from data.
• Good project management skills.
• Ability to respond to changing priorities and handle multiple tasks at one time.

ESSENTIAL JOB DUTIES

• Ensures all pharmacy and 3PL license renewals are completed on time.
• Leads payor credentialing activities, ensuring all completed on time.
• Manages deviation management reporting, CAPA, and closure of any reported quality events within quality management system. Assists with trend analysis to identify opportunities for improvement and reports to Quality Management Committee.
• Participates and helps with coordination of customer-initiated audits, including preparation, audit hosting, audit responses (both internal and client reporting), as well as any needed corrective action plans and effectiveness checks as needed.
• Performs periodic internal audits as assigned to ensure regulatory and accreditation compliance and re-accreditation. Track audit results in quality management platform, identifies deficiencies and work with management to ensure all deficiencies addressed
• Special projects as assigned

EMPLOYEE BENEFITS

• BCBSL Medical
• Delta Dental
• EyeMed Vision
• 401k
• Accident & Critical Illness
• Life Insurance
• PTO, Holiday Pay, and Floating Holidays
• Tuition Reimbursement