Manager, Cord Blood Bank Quality

The University of Texas MD Anderson Cancer Center is a leading institution focused on cancer care, research, education, and prevention. 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.

UT MD Anderson is recognized worldwide for its commitment to advancing patient care through innovation, scientific discovery, education, and operational excellence. The Manager of Cord Blood Bank Quality partners with laboratory, operational, and clinical teams while serving as the independent Quality Unit leader. The Manager of Cord Blood Bank Quality ensures compliance with regulatory, accreditation, and institutional standards while supporting delivery of safe, high-quality products for transplantation and cellular therapy.

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.

This role offers the opportunity to lead quality and regulatory excellence within a highly specialized cord blood banking program that directly supports patient care and cellular therapy initiatives. Working at UT MD Anderson provides exposure to leading-edge healthcare operations, collaboration with multidisciplinary experts, opportunities for professional growth, and the ability to make a meaningful impact on patient safety, product quality, and regulatory compliance.

• Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance.
• Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.
• Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.
• Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.

• 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…