Director 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: $110K-$160K

POSITION SUMMARY

The Director, Quality Management 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 ensuring ongoing compliance with all applicable regulations and license 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 position requires 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 per month.

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 in collaboration with Dir, Learning and Development.
• Ensure proper coordination of customer-initiated audits, internal audits, regulatory inspections, as well as follow up of corrective action plans and effectiveness checks
• 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.
• 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

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