Senior Cord Blood Bank Quality Leader

UT MD Anderson; Houston (TX); On-site; USD 118,000 - 176,000; Full time

Benefits offered by this job

Employer-paid medical coverage (day 1)

PTO accruals and extended illness bank

Tuition Assistance Program

Defined-benefit pension

Job summary

The University of Texas MD Anderson Cancer Center is seeking a Manager of Cord Blood Bank Quality to lead quality systems and regulatory readiness for a licensed cord blood program. This senior role collaborates with clinical, laboratory, and operational teams, ensuring patient safety, product quality, and compliance with FDA biologics licensure, cGMP, FACT and CAP standards.

Responsibilities include leading QA reviews, inspections, and continuous improvement initiatives while guiding staff and

Qualifications

• Five years in cord blood/blood/tissue banking, cellular therapy, medical research, transplantation, or healthcare administration, with three years of lead/supervisory experience.
• Must pass pre-employment skills test as required by Human Resources.

Responsibilities

• Provide leadership and oversight of the Quality Management System (QMS), ensuring compliance with licensure requirements and standards.
• Lead regulatory inspections, accreditation assessments, self-inspections and audit programs; coordinate responses and corrective actions.
• Manage deviations, investigations, adverse events, 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.

Skills

Leadership

Regulatory knowledge

Quality systems

FDA regulations

Biologics experience

Education

Bachelor's Degree in a related field

Job description

The University of Texas MD Anderson Cancer Center is seeking a Manager of Cord Blood Bank Quality to lead quality systems and regulatory readiness for a licensed cord blood program. This senior role collaborates with clinical, laboratory, and operational teams, ensuring patient safety, product quality, and compliance with FDA biologics licensure, cGMP, FACT and CAP standards.

Responsibilities include leading QA reviews, inspections, and continuous improvement initiatives while guiding staff and