Manager, Quality Assurance | Donor Center

Essential Responsibilities

• Provide quality leadership and guidance to Donor Center operations, promoting a culture of compliance, accountability, and continuous improvement.
• Lead implementation, maintenance, and improvement of the Quality Management System to support regulatory compliance and business objectives.
• Oversee quality metrics, trend analysis, risk assessments, and performance monitoring to identify improvement opportunities and mitigate compliance risks.
• Lead Quality Management Reviews for assigned sites and ensure effective evaluation of quality system performance, audit results, customer feedback, risks, and improvement initiatives.
• Serve as the primary quality lead for customer audits, regulatory inspections, and compliance readiness activities.
• Review and approve deviations, nonconformances, complaints, investigations, CAPAs, and change controls, ensuring timely closure and effectiveness.
• Facilitate root cause investigations using risk-based and structured problem-solving methodologies.
• Participate in and provide guidance to Deviation Review Boards, Change Control Review Boards, Material Review Boards, and Quality Review Boards.
• Develop, review, and maintain SOPs and quality procedures to ensure standardized practices across Donor Centers.
• Oversee training program effectiveness and ensure personnel are qualified to perform assigned responsibilities.
• Support donor file review, product disposition, and release activities to ensure compliance with regulatory, quality, and customer requirements.
• Conduct internal audits, facility inspections, and quality system assessments to verify ongoing compliance and identify improvement opportunities.
• Review and approve equipment, process, computerized system validation, and qualification activities as assigned.
• Maintain QA records and documentation in accordance with record retention and archival requirements.
• Partner with clients, suppliers, and cross-functional stakeholders to provide quality and regulatory guidance that supports organizational goals.

Qualifications

• Strong knowledge of Quality Management Systems, GMP, GDP, quality risk management, and regulatory compliance.
• Experience leading investigations, CAPA programs, audits, inspections, and quality improvement initiatives.
• Knowledge of applicable FDA, state, and industry regulations governing donor center, laboratory, biologics, or tissue-related operations.
• Excellent leadership, communication, organizational, and problem-solving skills.
• Demonstrated ability to influence cross-functional teams and drive compliance in a dynamic operational environment.

Work Environment & Travel

Hybrid Position. Employee must maintain a dedicated home workspace and reliable internet connection when working remotely. Expected onsite presence of at least three (3) days per week. Travel to donor centers and other company locations approximately once per month or as business needs require.