Senior Quality and Donor Eligibility Manager

The Senior Quality and Donor Eligibility Manager is responsible for the day-to-day execution and maintenance of the Lions World Vision Institute (LWVI) Quality Management System, including both Donor Eligibility Determination and Donor Information Systems, ensuring operational compliance with FDA HCT/P requirements, accreditation standards, and internal policies. Reporting to the Quality Assurance Director, this role provides hands‑on leadership for quality processes, donor eligibility determination, donor information systems, medical director consultations, investigations, audits, training, and continuous improvement initiatives, while partnering with operational teams to identify and mitigate compliance risks while maximizing organizational impact.

The Senior Quality and Donor Eligibility Manager plays a critical role in maintaining inspection readiness, supporting safe and compliant operations, and advancing the organization’s mission and quality objectives.

This job description includes, but does not limit, the primary duties, qualifications, and scope of this role at LWVI.

• Oversee day-to-day execution of the Quality Management System (QMS) and ensure consistent implementation across all operations.
• Oversee day-to-day medical review operations for Donor Information and Donor Eligibility Determination by Medical Director or designee.
• Communicates with Operations leadership including laboratory operations to ensure quality and efficiency of tissue throughput, tissue not suitable (NSFS) and recovery initiatives to maximize donation impact and meet organizational strategic initiatives.
• Manage and maintain controlled documents, records, and change control processes to ensure ongoing regulatory compliance.
• Lead investigations of deviations, nonconformances, adverse events, and complaints; perform root cause analysis in conjunction with department leadership and manage CAPA activities to closure.
• Coordinate and support regulatory inspections, audits, and assessments, including preparation, hosting support, response development, and follow‑up actions.
• Builds and maintains relationships with partner organizations to oversee donor record days on hand, first pass yield and documentation compliance.
• Oversee internal audits and vendor/partner audits; track and verify timely completion of corrective actions.
• Develop and monitor departmental and individual goals and metrics in conjunction with the Donor Eligibility Manager and the Director of Quality Assurance.
• Supervise environmental monitoring, validations, and qualifications for facilities, equipment, and processes in collaboration with Operations.
• Ensure training and competency programs are executed, documented, and maintained in compliance with regulatory and accreditation requirements.
• Monitor quality metrics and trends; prepare reports and escalate risks, compliance issues, and improvement opportunities to the QA Director.
• Provide hands‑on guidance to operational teams on SOP adherence, regulatory expectations, and quality best practices.
• Support continuous improvement initiatives and cross‑functional projects as assigned by the QA Director.
• Maintain direct reports individual development plans, performance reviews, and corrective actions.
• Drives process improvement initiatives for donor eligibility and donor information systems.
• Provides input to the budget upon request by the Director of Quality Assurance.
• Maintain relationships with Medical Directors and contracted physicians, including oversight of consults, donor eligibility determination, and training.
• Maintain current knowledge of FDA, relevant state, and OSHA regulations as well as AATB and EBAA standards; keep informed on industry changes, trends, and best practices.
• Additional duties as assigned.

• Must have strong verbal, written, and analytical skills.
• Knowledge of EBAA and AATB Standards and FDA regulations.
• Effective interpersonal skills: ability to develop and maintain positive relationships with professional contacts, resources and/or networks and deal with people with sensitivity, tact, discretion and professionalism.
• Ability to work…