Accreditation & Quality Specialist

Job Description

Job Description

About Shields Advanced Therapies

Shields Advanced Therapies partners with health systems to accelerate advanced therapy access and operations, ensuring lifechanging breakthroughs reach more patients. Our management services and technology solutions serve as a horizontal support hub to empower health system-led, world-class advanced therapy care across 50+ disease states. Launched in September 2024, Shields Advanced Therapies is anchored by partnerships with four of the Top 20 Academic Medical Centers in the United States. Additionally, Shields' track record partnering with over 1,000 hospitals across 43 states in prior ventures provides a national channel for expansion.

Role Overview

The Accreditation & Quality Specialist plays a central role in ensuring the Advanced Therapy Program maintains compliance with the Foundation for the Accreditation of Cellular Therapy (FACT) standards, as well as institutional, state, and federal regulatory requirements. This position coordinates all aspects of the accreditation process, including document management, quality audits, training compliance, and continuous quality improvement (CQI) initiatives. The specialist will serve as a subject matter expert on FACT standards, liaise with multidisciplinary stakeholders, and drive a culture of excellence and accountability in patient care and product handling.

Core Responsibilities

• FACT Accreditation & Compliance

  • Lead and coordinate the preparation, submission, and maintenance of FACT accreditation for applicable services (e.g., hematopoietic cell transplantation, immune effector cell therapy, processing lab)
  • Maintain detailed documentation to demonstrate ongoing compliance with FACT standards
  • Develop, revise, and manage standard operating procedures (SOPs), policies, and documentation as required by FACT and internal governance
  • Collaborate with clinical, laboratory, and administrative teams to prepare for FACT inspections and address corrective actions or deficiencies

  Quality Program Coordination

  • Support and monitor the program's quality management plan, including the collection and review of quality indicators and adverse event tracking
  • Coordinate regular Quality Management Committee meetings, including agenda preparation, minute taking, and follow-up on action items
  • Maintain training documentation and ensure staff competencies are up to date in accordance with regulatory and accrediting body requirements
  • Assist in the identification and implementation of continuous quality improvement (CQI) initiatives

  Audit & Inspection Readiness

  • Lead internal audits and mock inspections to assess readiness and identify gaps
  • Serve as a point of contact and escort during external FACT inspections and audits
  • Compile and maintain evidence binders, document logs, CAPA (corrective and preventative action) responses, and timelines for accreditation and re-accreditation activities

  Regulatory Alignment & Support

  • Ensure alignment with additional regulatory requirements from agencies such as the FDA, AABB, CLIA, CAP, and state boards
  • Stay current with updates to FACT standards and applicable federal/state regulations; educate staff on relevant changes

Location

Hybrid (Boston, MA & Remote)

Experience

• • Registered Nurse - MA
  • Bachelor's degree in healthcare, life sciences, public health, quality management, or a related field
  • Minimum 2-4 years of experience in healthcare quality, regulatory compliance, or accreditation-preferably in a cellular therapy, BMT, or laboratory environment
  • Demonstrated knowledge of FACT standards and accreditation processes
  • Strong organizational and documentation skills; proficiency in Microsoft Office Suite

Compensation

• Competitive base salary with bonus opportunity tied to outcomes metrics.

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