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SalaryAbout 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 Director, Quality Assurance will be responsible for leading the quality management program for Orsini which will include oversight of document management, audit and inspection programs, deviation and CAPA management, as well as vendor management. The Director will provide insights, analyses and support in the promotion and assessment of risk, compliance with regulations, accreditation standards, and operating procedures.
REQUIRED KNOWLEDGE, SKILLS, & TRAINING:
- Undergraduate degree in Business, Healthcare, or related field required.
- 5 + years Quality Assurance experience with specialty pharmacy or healthcare related area.
- 3+ years management experience required.
- Experience in healthcare or Specialty Pharmacy and URAC/ACHC experience preferred.
- Excellent written and verbal presentation skills.
- Effective organization, communication, and team orientation skills.
- Considerable knowledge of Quality Assurance processes and procedures with Quality and Privacy certifications preferred.
- Ability to identify, analyze, and solve complex problems.
- Ability to present to senior management on sensitive topics.
- Ability to establish and maintain effective relationships with clients.
- Demonstrated ability to lead and manage multiple responsibilities.
ESSENTIAL JOB DUTIES:
- Leads all document management activities including development, version control, and ongoing review of SOPs, work instructions and resource documents. Ensure proper training records are maintained.
- Ensure proper coordination of customer-initiated audits, internal audits, regulatory inspections and manage regulatory facility inspections, as well as follow up of corrective action plans and effectiveness checks.
- Ensures accreditation standards are maintained and re-accreditations are successfully completed.
- Oversees deviation management reporting, CAPA, and closure of significant compliance issues. Conducts trend analysis to identify areas for continuous improvement and reports to senior management.
- Leads vendor management processes.
- Manage staff in accordance with organizations policies and applicable regulations including resource management, appraising performance, rewarding, and disciplining employees as needed and guiding professional development.
- Participate in or lead teams for special projects as assigned.
EMPLOYEE BENEFITS:
- BCBSIL Medical
- Delta Dental
- EyeMed Vision
- 401k
- Accident & Critical Illness
- Life Insurance
- PTO, Holiday Pay, and Floating Holidays
- Tuition Reimbursement
