Director Clinical Quality & Management - 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: $120K-$170K

POSITION SUMMARY

The Director, Clinical Quality Management will be responsible for leading the clinical quality management program for Orsini which will includes oversight of accreditation compliance, internal audit for clinical activities, and leadership of the clinical review committee. These clinical oversight activities will include document management, audit and inspection programs, and deviation and CAPA management. The Director will provide insights, analyses and support in the promotion and assessment of risk, compliance with regulations, accreditation standards, and operating procedures. This role involves periodic travel to partner sites, conferences, or corporate meetings.

REQUIRED KNOWLEDGE, SKILLS & TRAINING

• Undergraduate degree in Business, Healthcare, or related field required.
• 5 + years quality experience with specialty pharmacy or healthcare related area
• 3+ years management experience required
• Experience in healthcare or Specialty Pharmacy 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
• Ability to travel approximately once to two times per quarter

ESSENTIAL JOB DUTIES

• Leads oversight of all accreditation activities, ensuring compliance and ongoing accreditation renewal. Serve as liaison to accreditation organizations, coordinate accreditation survey preparation and on-going compliance with accreditation standards via internal audit activities.
• Develops and executes an internal audit plan for key clinical activities. 
• Leads the Clinical Review Committee, including agenda preparation, meeting execution, meeting minutes, and ensuring proper follow up activities and agreed upon initiatives are completed.  
• Responsible for document management and deviation and CAPA activities for clinical activities.  
• Conducts trend analysis to identify areas for continuous improvement and reports to senior management.
• Participate in or lead teams for 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