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About Shields Advanced Therapies partners with health systems to accelerate advanced therapy access and operations, ensuring life-changing 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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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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