About Boulder Biologics Research Center

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.

Position Summary

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 role is responsible for:

• Designing, implementing, and enforcing the BBRC Quality Management System
• Leading AABB CTS accreditation and ongoing compliance
• Overseeing MES-driven GMP workSlows
• Providing quality oversight for same-day and expanded autologous MSC processing

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.

In a lean, early-stage environment, the Quality Director is expected to have broad crossfunctional involvement across quality, manufacturing, clinical, regulatory, and systems initiatives, while maintaining independent quality authority and without assuming operational ownership of non-quality functions.

Core Accountability

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

Key Responsibilities

Quality Leadership & Governance

• 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.

Quality System Architecture & Policy Control

• 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 notiSications.

Manufacturing Execution System (MES) Oversight

• Provide quality governance and oversight for the implementation and ongoing use of an MES supporting cellular therapy manufacturing, including:
  • Chain of Identity (COI) and Chain of Custody (COC)
  • Electronic batch records
  • Reagent and lot traceability
  • Equipment integration and data integrity
• 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.

Cellular Therapy Quality Oversight

• Provide end-to-end quality oversight for cellular therapy activities across manufacturing, testing, release, and patient-interfacing clinical workflows, ensuring documentation integrity, traceability, and appropriate product disposition. Define, approve, and enforce product release criteria, acceptance thresholds, and quality control checkpoints in accordance with the QMS and applicable regulatory and accreditation requirements.
• Such oversight includes, but is not limited to:
  • Same-day autologous BMA/BMAC and biologic preparation
  • Expanded MSC culture, release, and storage
  • Environmental monitoring programs (ISO 5/7/8 classiSied environments)
  • Equipment qualification and validation (IQ/OQ/PQ)

Deviation Management & CAPA

• Lead and oversee investigations of deviations, nonconformances, and other quality events impacting cellular therapy operations and quality systems.
• Develop, implement, and track CAPAs through completion with documented effectiveness checks.
• Perform trend analysis and risk assessments to identify systemic issues and support ongoing management review and continuous improvement.
• Establish escalation pathways and ensure significant quality events, trends, and risks are communicated to executive management and integrated into management review.

Adverse Event Support & Escalation

• Provide quality oversight and support clinical and regulatory teams in the investigation, documentation, and quality impact assessment of adverse events and serious adverse events.
• Ensure appropriate linkage between adverse event handling and the quality system, including identification of related deviations, CAPAs, regulatory reporting considerations, and management review inputs.
• Establish escalation pathways for serious adverse events to executive management and ensure appropriate quality system and regulatory actions are initiated.

Training & Personnel Competency

• Establish and oversee CTS training, qualification, and competency systems, including job descriptions, personnel qualification criteria, competency assessment programs, training records, and continuing education requirements, in alignment with applicable AABB standards and quality system requirements.
• Ensure initial, ongoing, and post-event competency assessments are conducted, documented, and maintained using appropriate risk-based methods.
• Partner with laboratory and clinical leadership on staffing models, role definition, training needs, and remediation plans.

Clinical–Laboratory Integration

• Ensure quality continuity across patient harvest, processing, and administration workflows.
• Collaborate with clinical leadership to support documentation integrity, Chain of Identity (COI)/Chain of Custody (COC) continuity, and the recognition, escalation, and quality system linkage of adverse events.
• Provide quality oversight for translational clinical activities involving investigational cellular therapies under IRB/IND oversight.
• Support executive management and clinical leadership in establishing quality oversight frameworks for clinical interfaces and translational cellular therapy programs.

Education and Minimum Experience

• Advanced degree (Master’s or PhD) in a relevant scientific, biomedical, or engineering discipline or a Bachelor’s degree in a related field with significant, progressively responsible experience leading quality systems in cellular therapy, blood banking, tissue services, or other regulated laboratory environments. Candidates must demonstrate education, training, and experience sufficient to fulfill the responsibilities of the role, consistent with AABB requirements.
• At least 8 years of progressive experience in Quality Assurance and Quality Compliance within regulated life sciences. Education may be considered in lieu of experience.
• Must have working experience in a GMP-regulated facility, with a strong understanding of quality and regulatory principles consistent with industry best practices.

Required Core Experience & Skills

• Significant hands-on experience in cellular therapy, blood banking, tissue services, or comparable regulated laboratory environments (e.g., MSC, HPC, immune cell, or equivalent).
• Demonstrated leadership experience operating in a senior quality or program-level role within a regulated laboratory, cellular therapy, or translational research environment.
• Working knowledge of Quality Management Systems and regulated laboratory operations, with documented experience in:
  • SOP lifecycle management
  • Equipment qualification and validation
  • Environmental monitoring programs
  • Deviation investigation and CAPA
  • Personnel training and competency assessment
• Familiarity with Slow cytometry QC, sterility testing, and cell characterization assays in a regulated environment.
• Strong technical writing, verbal communication, and presentation skills.
• High attention to detail, strong documentation practices, and sound data integrity/GDP principles.

Preferred Experience

• Demonstrated leadership in AABB CTS accreditation or reaccreditation.
• Experience with Manufacturing Execution Systems (MES) in GMP or CTS operations.
• Experience overseeing same-day autologous and expanded cellular therapy programs.
• Experience supporting IND submissions and/or IRB-regulated translational research.
• Exposure to IND-enabling or early-phase clinical research.
• Experience integrating clinical EMR systems with laboratory QMS/MES infrastructure.
• Knowledge of manufacturing operations, manufacturing equipment, process development, and operational excellence frameworks