Senior Manager, Cord Blood Bank Quality

UT MD Anderson Cancer Center•Houston, TX

About The Position

The Senior 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) to manufacture HPC, Cord Blood and accredited by FACT and CAP. The role serves as the independent Quality Unit leader and a collaborative partner to operational and laboratory teams, ensuring compliance 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. It serves as the Cord Blood Bank's primary quality representative for FDA biologics licensure activities, submissions, and regulatory strategy. The role promotes quality, continuous improvement, patient safety, regulatory readiness, and operational excellence through oversight of quality systems, risk management, process controls, and quality metrics. The position leads and develops Quality Unit personnel, manages quality and regulatory programs, supports inspection and accreditation readiness, and provides quality oversight of facility, cleanroom, environmental monitoring, aseptic processing, equipment, and manufacturing processes. It makes independent product disposition decisions for cord blood units intended for registry listing, transplantation, cellular therapy, research, or further manufacturing. The role is based in Houston, Texas. The stated annual salary range is $135,975 minimum, $169,000 midpoint, and $204,000 maximum. The position may be responsible for maintaining the security and integrity of critical infrastructure and may require routine reviews and screening.

Requirements

Bachelor's degree in biological sciences or a related field.
Seven years of progressive healthcare or clinical laboratory experience.
Three years of supervisory experience.
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 may substitute for a maximum of two years.
Must pass a pre-employment skills test if required and administered by Human Resources.
Ability to satisfy and maintain requirements necessary to ensure the continued security and integrity of critical infrastructure, if applicable to the position.
Expertise in quality management systems, FDA-regulated biologics manufacturing, cGMP and cGTP compliance, accreditation standards, quality risk management, and regulatory inspections is described as ideal.

Nice To Haves

Master's degree in business or a healthcare-related field.
Experience leading quality teams in cellular therapy, blood banking, tissue banking, biologics, or related healthcare manufacturing environments.

Responsibilities

Lead and oversee the Quality Management System to maintain 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.
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, 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, Changes Being Effected submissions, regulatory commitments, and post-marketing requirements.
Assess the impact of new FDA regulations, guidance, enforcement trends, and accreditation standards, and develop implementation strategies.
Collaborate with program leadership to maintain compliance with 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 quarterly and annually.
Lead personnel training, competency, and quality education programs, including safety and cGMP training.
Monitor regulatory guidance, accreditation standards, and industry best practices, and implement required changes.
Supervise, coach, mentor, and manage the performance of Quality Unit personnel; establish goals, expectations, competency requirements, and development plans.
Develop succession planning, staff development, cross-training, knowledge transfer, and leadership development strategies for quality staff.
Promote a collaborative quality culture of accountability, transparency, proactive risk identification, and continuous improvement.
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 before product listing and distribution.
Review batch and product records to verify conformance with licensed manufacturing processes and specifications.
Approve Internal Quality Assessment 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 involving cord blood units intended for registry listing, transplantation, cellular therapy, research, or further manufacturing.
Base product release decisions on review of donor and manufacturing records, testing results, deviations, investigations, and licensure requirements.
Approve, reject, quarantine, or recall products when quality, safety, or regulatory concerns are identified.
Partner with clinical, laboratory, and operational leaders to evaluate product risks and 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 before use.
Support transplant centers, registry partners, and clinical stakeholders by ensuring product quality, traceability, and compliance.
Provide quality oversight of facility, cleanroom, environmental monitoring, and aseptic processing programs.
Collaborate with Operations leadership to optimize manufacturing processes while maintaining 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 for regulatory compliance and product protection.
Oversee proficiency testing programs and review their 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 product quality indicators.
Collaborate with operations, laboratory, clinical, and support departments to identify risks, optimize processes, and strengthen product quality and patient safety.
Ensure quality records, equipment files, and validation documentation are inspection-ready and readily retrievable.
Lead cross-functional quality reviews to evaluate trends, identify emerging risks, and prioritize improvement initiatives.
Support strategic planning for facility, equipment, process, and technology enhancements by evaluating compliance, qualification, and quality implications.
Perform other duties as assigned.

Benefits

Employer-paid medical coverage starting day one for employees working 30 or more hours per week.
Optional group dental, vision, life, AD&D, and disability insurance.
Accruals for PTO and an Extended Illness Bank.
Paid holidays and other leave options, including wellness and childcare leave.
Tuition Assistance Program after six months of service.
Access to wellness, fitness, and employee resource groups.
Defined-benefit pension through the Teachers Retirement System.
Voluntary retirement plans.
Employer-paid life and reduced salary protection programs.
Professional development opportunities and educational opportunities.
Individual and team recognition.