Director of Quality & Cellular Therapy Systems, Quality Representative; AABB CTS

Organization: Boulder Biologics Research Center (BBRC)

Location: Boulder, Colorado

Work Arrangement: On-site only

Employment Type: Full-time, Exempt

Reports To: Executive / Medical Leadership

Boulder Biologics Research Center (BBRC) is an integrated clinical and translational research organization operating at the intersection of interventional orthopedics, translational neuroscience, and GMP-aligned autologous cellular therapy manufacturing. BBRC supports both same-day biologic procedures and expanded cellular therapy programs, with a focus on mesenchymal stromal/stem cells (MSCs)-based applications.

BBRC is developing and maintaining a Cellular Therapy Services (CTS) program aligned with AABB standards, supported by evolving quality systems and regulatory infrastructure to enable translational research and clinical administration of autologous cellular therapies.

BBRC is seeking an experienced, hands-on Director of Quality & Cellular Therapy Systems to serve as the institutional quality and regulatory authority for cellular therapy operations.

This position is intentionally designed as a hands-on Quality Director role within a lean, early-stage organization. The Director retains direct ownership of the Quality Management System and is expected to be actively involved in SOP development, audits, deviation management, and accreditation preparation. While the role carries formal quality authority across cellular therapy operations, it does not initially include management of a large QA team.

This is a hands-on, on-site Quality Director role with formal authority over laboratory quality decisions, deviation management, product release oversight, and the ability to halt processing when quality or patient safety is at risk, as required by AABB CTS standards.

The Quality Director is expected to have broad cross-functional involvement across quality, manufacturing, clinical, regulatory, and systems initiatives, while maintaining independent quality authority and without assuming operational ownership of non-quality functions.

The BBRC QA Director will be responsible and accountable for ensuring that BBRC maintains a comprehensive, executive-supported quality system governing:

• Cellular therapy procurement, processing, storage, testing, and administration

• Personnel qualification, training, and competency systems

• Risk management, deviation management, and continuous improvement

• Accreditation, inspection readiness, and relevant regulatory communication

• Emergency preparedness and operational continuity

• Human subject research quality oversight

• Serve as Quality Director for BBRC’s Cellular Therapy Services program.
• Establish and maintain a comprehensive QMS compliant with applicable AABB Cellular Therapy Standards and relevant regulatory requirements.
• Lead formal management review process and quality systems evaluations.
• Exercise documented authority to restrict or suspend processing activities if quality, compliance, or safety concerns arise.

• Design and maintain BBRCs quality policies, processes, and procedures governing all CTS activities.
• Lead accreditation and reaccreditation activities, including gap assessments, corrective action planning, and engagement with accrediting bodies and auditors.
• Ensure compliance with applicable FDA regulations, AABB requirements, and GMP principles for autologous cellular therapies.
• Maintain continuous inspection readiness across processing, equipment, documentation, and personnel competency systems.
• Serve as the quality authority for regulatory and accreditation communications, including inspection coordination, reportable events, and required notifications.

• Ensure MES alignment with QMS, regulatory expectations, and audit trails, in coordination with operations and IT functions.
• Serve as the quality authority for data integrity, electronic records compliance, and system validation activities related to the MES.
• Provide quality governance and oversight for the implementation and ongoing…