What are the responsibilities and job description for the Quality Manager-Remote position at Orsini Pharmaceutical Services?
Description
About Orsini Specialty Pharmacy
Providing patients with comprehensive and compassionate care since 1987, Orsini Specialty Pharmacy is a leader in rare diseases and gene therapies. Orsini partners with biopharma innovators, healthcare providers, and payors to support patients and their families in accessing revolutionary treatments for rare diseases. Through integrated pharmacy distribution, patient services, clinical management and convenient home infusion services, Orsini delivers customized solutions that simplify how patients connect to advanced therapies. Orsini’s high-touch care model centers on experienced and trained therapy care teams that provide personalized patient care to ensure that No Patient is Left Behind™. Orsini Specialty Pharmacy holds accreditations with the Accreditation Commission for Health Care (ACHC), The Joint Commission, URAC and NABP. Orsini has earned URAC’s Rare Disease Pharmacy Center of Excellence Designation and ACHC's Distinction in Rare Diseases and Orphan Drugs.
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
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 license 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
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 license 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.
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.
- 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
