Senior Manager, Cord Blood Bank Quality

The Sr. Manager, Cord Blood Bank Quality provides strategic and operational leadership for the Quality Management System of a public cord blood bank licensed by the U.S. Food and Drug Administration (FDA) for the manufacture of HPC, Cord Blood and accredited by FACT and CAP. 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. This position also serves as the Cord Blood Bank’s primary quality representative for FDA biologics licensure activities, submissions and regulatory strategy. 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 possess significant expertise in quality management systems, FDA-regulated biologics manufacturing, cGMP and cGTP compliance, accreditation standards, quality risk management, and regulatory inspections. Experience leading quality teams within cellular therapy, blood banking, tissue banking, biologics, or related healthcare manufacturing environments is highly desirable.

Annual Salary Range:
Minimum $135,975 — Midpoint $169,000 — Maximum $204,000

Work Location:

Houston, TX

This position offers the opportunity to lead quality and regulatory strategy for a highly specialized cord blood banking program that directly supports transplantation and cellular therapy patients worldwide. The role provides exposure to advanced biologics manufacturing, FDA licensure activities, accreditation programs, and cross-functional leadership initiatives while contributing to UT MD Anderson’s mission of eliminating cancer and advancing patient care. Team members benefit from meaningful work, professional development opportunities, and programs that support personal well-being and long-term career growth.

• 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…