The Manager of Cord Blood Bank Quality serves in a critical leadership role supporting a public cord blood bank licensed by the U.S. Food and Drug Administration for the manufacture of HPC, Cord Blood and accredited by FACT and CAP. The Manager of Cord Blood Bank Quality provides strategic and operational leadership for quality systems, regulatory compliance, product release, patient safety, and continuous improvement activities that support high standards of cellular therapy manufacturing.
This role serves as the independent Quality Unit leader and collaborative partner to operational and laboratory teams, ensuring that all activities comply with applicable FDA regulations, biologics license requirements, cGMP, cGTP, FACT, CAP, NMDP, HRSA and institutional standards. The position is accountable for final quality review and approval of cord blood units for registry listing, product release and clinical distribution. The role drives a culture of quality, continuous improvement, patient safety, regulatory readiness and operational excellence through oversight of quality systems, risk management, process controls and quality metrics.
The ideal candidate will have people management experience in a relevant field. Regulatory experience in biologics is also preferred.
Salary Range: Minimum $117,600 - Midpoint $146,500 - Maximum $176,400
Typical Work Schedule: M - F, day time hours. May need to be flexible based on business operations.
Work Location: Onsite. Houston, TX.
Responsibilities
Quality Leadership, Regulatory Compliance & Continuous Improvement
- Provide leadership and oversight of the Quality Management System (QMS), ensuring continuous compliance with FDA licensure requirements, cGMP, cGTP, FACT, CAP, NMDP and other applicable standards.
- Lead regulatory inspections, accreditation assessments, self-inspections and audit programs; coordinate responses and corrective actions.
- Manage deviations, investigations, adverse events, biological product deviations, recalls, CAPA, risk management and change control programs.
- Direct document control including review, approval and revision of SOPs, policies, forms and controlled documents.
- Review and approve process validations, assay validations, equipment qualifications and media qualifications.
- Oversee vendor qualification and supplier quality management activities including external audits.
- Serve as the Cord Blood Bank's primary quality representative for FDA biologics licensure activities and regulatory strategy.
- Provide quality oversight and review of BLA-related submissions, annual reports, Prior Approval Supplements (PAS), Changes Being Effected (CBE-30) submissions, regulatory commitments, and post-marketing requirements.
- Assess the impact of new FDA regulations, guidance documents, enforcement trends, and accreditation standards on licensed operations and develop implementation strategies.
- Collaborate with program leadership to ensure continued compliance with all obligations associated with FDA licensure for HPC, Cord Blood.
- Lead inspection readiness activities and coordinate responses to FDA observations, accreditation findings, and regulatory inquiries.
- Develop, trend and report quality performance indicators and quality management reports on a quarterly and annual basis.
- Lead personnel training, competency and quality education programs including safety and cGMP training.
- Maintain ongoing surveillance of regulatory guidance, accreditation standards and industry best practices and implement required changes.
- Provide direct supervision, coaching, mentoring, and performance management of Quality Unit personnel.
- Establish annual goals, performance expectations, competency requirements, and development plans for quality staff.
- Develop succession planning strategies to ensure continuity of critical quality and regulatory functions.
- Build organizational quality expertise through staff development, cross-training, knowledge transfer, and leadership development activities.
- Foster a collaborative quality culture that promotes accountability, transparency, proactive risk identification, and continuous improvement across all functional areas.
Product Quality Review, Release & Patient Safety
- Provide independent final QA review and approval of cord blood unit records for listing on the national registry.
- Confirm donor eligibility determinations and licensure requirements prior to product listing and distribution.
- Perform batch record reviews and product record reviews to verify conformance with licensed manufacturing processes and specifications.
- Approve Internal Quality Assessment (IQA) results and final product disposition decisions.
- Authorize release and clinical distribution of cord blood units for transplantation, cellular therapy or further manufacturing.
- Serve as the final independent Quality Unit authority for disposition decisions affecting cord blood units intended for registry listing, transplantation, cellular therapy, research, or further manufacturing.
- Ensure product release decisions are based on complete review of donor records, manufacturing records, testing results, deviations, investigations, and applicable licensure requirements.
- Exercise authority to approve, reject, quarantine, or recall products when quality, safety, or regulatory concerns are identified.
- Partner with clinical, laboratory, and operational leaders to evaluate product-related risks and implement strategies that protect patient safety and product integrity.
- Manage urgent product disposition decisions including positive sterility findings, infectious disease marker results and other significant quality events.
- Generate and approve Certificates of Conformance and other release documentation.
- Review and approve collection label lots, reagents, supplies and critical materials prior to use.
- Support transplant centers, registry partners and clinical stakeholders by ensuring quality, traceability and compliance of released products.
Operational Quality Oversight, Process Control & Infrastructure
- Provide quality oversight of facility, cleanroom, environmental monitoring and aseptic processing programs.
- Collaborate with Operations leadership to optimize manufacturing processes while maintaining regulatory compliance and product quality.
- Review and trend environmental monitoring, sterility assurance, aseptic control and process performance data.
- Oversee quality review of equipment lifecycle activities including IQ/OQ/PQ, calibration, maintenance, repairs and requalification.
- Monitor critical equipment and facility systems, including continuous monitoring systems, alarms, investigations and corrective actions.
- Review facility outages, maintenance activities and cleaning records to ensure regulatory compliance and product protection.
- Oversee proficiency testing programs and review program outcomes.
- Review transportation monitoring, processing summaries and process-control data to identify risks and improvement opportunities.
- Trend critical cord blood banking attributes including viability, recovery, CD34 cell content and other key product quality indicators.
- Collaborate closely with operations, laboratory, clinical and support departments to proactively identify risks, optimize processes and strengthen product quality and patient safety.
- Ensure all quality records, equipment files and validation documentation are inspection-ready and readily retrievable.
- Review and trend environmental monitoring, sterility assurance, aseptic control and process performance data.
- Lead cross-functional quality reviews to evaluate trends, identify emerging risks, and prioritize quality improvement initiatives.
- Support strategic planning for facility, equipment, process, and technology enhancements by evaluating compliance, qualification, and quality implications.
Other duties as assigned.
EDUCATION- Required: Bachelor's Degree In a related field.
WORK EXPERIENCE- Required: Five years In cord blood/blood/tissue banking, cellular therapy, medical research, transplantation, or healthcare administration, to include three years of lead/supervisory experience.
- May substitute required education degree with additional years of equivalent experience on a one to one basis.
- Successful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience. Completion of both programs can be substituted for a maximum of two years of supervisory or management experience.
OTHER REQUIREMENTS: Must pass pre-employment skills test as required and administered by Human Resources.
The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.
