Quality Manager
Description
About Orsini Specialty Pharmacy
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
Position Summary
Salary Range: $70K-$85K
The Quality Manager will be responsible for supporting all aspects of the quality management systems at Orsini, including document control, internal and external audit, deviation and CAPA management, and vendor management. The quality manager 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.
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.
- This position requires travel approximately 10–25 % of the time
Essential Job Duties
- Supports document management of all quality documents via quality management platform, ensuring version control, proper review and approval, and compliance with Orsini, client, regulatory, and accreditation standards
- Serve as liaison to accreditation organizations, coordinate accreditation survey preparation and on-going compliance with accreditation standards via internal audit activities
- Perform periodic internal audits 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
- Leads 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
- Oversees deviation management reporting, CAPA, and closure of any reported quality events within quality management system. Conducts trend analysis to identify opportunities for improvement and reports to Quality Management Committee
- Ensures all pharmacy and 3PL license renewals are completed on time
- Leads Vendor Management processes
- 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