Boulder Biologics Research Center · 4 days ago
Director of Quality & Cellular Therapy Systems, Quality Representative (AABB CTS)
Boulder, CO
Full-time
Onsite
Director/Executive
$100K/yr - $135K/yr
8+ years expBoulder Biologics Research Center (BBRC) is an integrated clinical and translational research organization focused on cellular therapy and related quality systems. The Director of Quality & Cellular Therapy Systems will oversee the quality management system, ensuring compliance with AABB standards while actively participating in SOP development, audits, and quality governance across cellular therapy operations.
Biotechnology
Responsibilities
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 use of an MES supporting cellular therapy manufacturing
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
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
Provide quality oversight and support clinical and regulatory teams in investigating, documenting, and assessing the quality impact 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
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
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
Qualification
Required
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
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
Familiarity with flow cytometry QC, sterility testing, and cell characterization assays in a regulated 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
Preferred
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
Benefits
Health, dental, and vision insurance
Paid time off and holidays
Retirement plan with employer contribution
Continuing education and professional development support
Company
Boulder Biologics Research Center
To transform patient care through the ethical, evidence-based application of regenerative and cellular medicine, focusing on chronic and degenerative diseases that lack durable treatment options, such as orthopedic injuries, neurodegenerative conditions, traumatic brain injury, and systemic diseases affecting the cardiopulmonary, hepatologic, renal, endocrine, and other organ systems.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase