Director, Quality Assurance - Xenotransplantation (DPF)

About the role

The Director, Quality Assurance – Xenotransplantation provides strategic and operational leadership for Quality Assurance systems supporting the manufacture, assessment, and release of designated pathogen-free (DPF) animal organs intended for human transplantation. This role ensures sustained compliance with FDA, USDA, and global GxP requirements while enabling operational execution across DPF site operations, animal care, laboratories, and manufacturing functions.

Responsibilities

• Provide strategic direction and governance for the DPF Quality Management System (QMS), ensuring compliance with cGMP, cGLP, cGCP (as applicable), FDA, USDA, and internal quality standards.
• Establish, maintain, and continuously improve QA policies, procedures, and programs supporting xenotransplantation and organ manufacturing activities.
• Own Quality oversight for deviations, investigations, CAPAs, change control, complaints, and product quality reviews.
• Ensure robust document control, data integrity, and record retention practices across animal care, laboratories, and manufacturing operations.
• Support regulatory and clinical efforts to reach FDA approval of animal organs for human transplant.
• Review documentation for accuracy, completeness, and compliance with United Therapeutics policies and procedures, and GxP/FDA/Clinical Trial/USDA requirements.
• Manage and lead controlled document collaboration, review, and approval.
• Perform Quality Assurance oversight activities to ensure compliance with current regulatory standards (e.g., deviation/failure investigations, change control documentation management, complaints, standard operating procedures, and product quality review).
• Review and write/update SOPs and reports to support these systems.
• Develop and provide guidance and direction regarding new initiatives and quality improvements; assess internal processes and procedures to ensure the most efficient utilization of resources; provide strategic advice and support to senior management and staff.
• Initiate and lead departmental and/or interdepartmental strategic objectives; translate strategy into operational and tactical plans.
• Lead FDA/USDA or other regulatory agency inspections; interpret direction from the inspection and react accordingly and quickly to mitigate potential problems; support the timely and accurate transfer of data, documents, and information to inspectors; act with discretion.
• Manage, coach, provide feedback, and review team's work, providing mentorship and professional development.
• Drive a culture of quality, accountability, ethical conduct, and continuous improvement.

Qualifications

• Bachelor’s Degree in science, engineering, or related field or Master’s Degree in science, engineering, or related field.
• 15+ years of experience in a GxP/FDA/USDA regulated environment.
• Extensive managerial experience with demonstrated people leadership, including conflict resolution, change management, coaching, and professional development.
• Experience managing FDA inspections.
• In‑depth Quality Assurance knowledge with applied expertise in GxPs/Quality Systems, FDA/USDA guidelines, and relevant industry standards.
• Ability to interpret data and apply GxP principles to company-specific procedures, processes, and products, including those related to organ assessment and preservation.
• Strong analytical judgment with exceptional problem-solving and risk assessment capabilities.
• Strong written and verbal communication skills, including professional documentation and the ability to independently produce high-volume, complex written materials.
• Ability to interact effectively across departments, including leading meetings and delivering presentations.
• Ability to review work performed by others, identify issues or deficiencies, enforce company policies and procedures, and drive corrective actions.
• Ability to handle confidential company data, projects, and information with discretion.
• Exceptional skills in problem and risk analysis/assessments.
• Ability to interpret data in relation to a vast number of company procedures as well as current GxP/Quality Systems/USDA/etc. requirements.
• Advanced analytical thought, judgment, and in-depth Quality Assurance knowledge.
• Competency in conflict resolution, change management, coaching, and professional development.
• Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures.
• Proficiency with Microsoft Excel, PowerPoint, Word, and Outlook.