Director, Quality Assurance - Xenotransplantation (DPF)

United Therapeutics Corporation•Houston, TX

3d•Onsite

About The Position

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. The role ensures sustained compliance with FDA, USDA, and global GxP requirements while enabling operations across DPF site operations, animal care, laboratories, and manufacturing. The Director serves as a senior Quality leader and partners with Site Operations, Animal Care, Facilities, Supply Chain, Regulatory Affairs, and R&D to drive inspection readiness, right-first-time execution, and continuous improvement in a novel, highly regulated manufacturing environment. The position leads strategic planning, direction, and goal setting for Xenotransplantation Quality Assurance; governs and improves the DPF Quality Management System; and oversees quality processes including deviations, investigations, CAPAs, change control, complaints, product quality reviews, document control, data integrity, and records retention. The role also reviews animal care, analytical, medical, clinical, protocol, environmental monitoring, and laboratory documentation; oversees materials and supplier qualification; and supports regulatory and clinical efforts toward FDA approval of animal organs for human transplantation. Additional duties include leading audits and regulatory inspections, coordinating validation activities, developing quality initiatives and improvements, and advising senior management and staff. The Director is responsible for planning, staffing, budgeting, and expense management, and for managing, coaching, and developing the team while promoting quality, accountability, ethical conduct, and continuous improvement. This position is based 100% onsite at the company’s Houston, Texas facility, five days per week when not traveling, and requires up to 25% travel. The employee must not have interaction with pigs outside of the company.

Requirements

Bachelor’s or master’s degree in science, engineering, or a related field.
15+ years of experience in a GxP-, FDA-, or USDA-regulated environment.
Extensive managerial experience and demonstrated people leadership, including conflict resolution, change management, coaching, and professional development.
Experience managing FDA inspections.
In-depth Quality Assurance knowledge and applied expertise in GxPs, Quality Systems, FDA and USDA guidelines, and relevant industry standards.
Ability to interpret data and apply GxP principles to company-specific procedures, processes, and products, including organ assessment and preservation.
Strong analytical judgment, 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, lead meetings, and deliver presentations.
Ability to review others’ work, identify deficiencies, enforce policies and procedures, and drive corrective actions.
Ability to handle confidential company data, projects, and information with discretion.
Proficiency with Microsoft Excel, PowerPoint, Word, and Outlook.
Must work in person at the company’s facilities five days per week when not on business travel.
Must not have interaction with pigs outside of the company.

Nice To Haves

12+ years of experience in animal husbandry, tissue bank, and/or cell processing environments.
Experience with TrackWise and MasterControl (eDMS) systems.
Working knowledge of Laboratory Information Management Systems (LIMS).
Experience with SAP S/4HANA.

Responsibilities

Set strategic plans, direction, and goals for the Xenotransplantation Quality Assurance function.
Provide strategic direction and governance for the DPF Quality Management System, ensuring compliance with cGMP, cGLP, cGCP as applicable, FDA, USDA, and internal standards.
Establish, maintain, and improve QA policies, procedures, and programs for xenotransplantation and organ manufacturing.
Own Quality oversight for deviations, investigations, CAPAs, change control, complaints, and product quality reviews.
Ensure document control, data integrity, and record retention across animal care, laboratories, and manufacturing operations.
Lead Quality Assurance support for regulatory and clinical efforts toward FDA approval of animal organs for human transplantation.
Review animal care, analytical, medical, clinical case, protocol, report, environmental monitoring, and laboratory documentation for accuracy, completeness, and compliance.
Oversee material receipt, inspection, release, and supplier qualification activities.
Manage controlled document collaboration, review, and approval; review and write or update SOPs and reports.
Provide prompt review of clinical case data and conduct Quality oversight activities to ensure compliance with current regulatory standards.
Perform internal and vendor audits, track corrections to observations, manage audit files, and summarize data to support annual product reports.
Assist Operations, Quality, and R&D with validation protocols and reports, and coordinate validation plans and tasks.
Develop guidance for new initiatives and quality improvements; assess processes and advise senior management and staff on efficient resource utilization.
Initiate and lead departmental and interdepartmental strategic objectives, translating strategy into operational and tactical plans.
Lead FDA, USDA, and other regulatory agency inspections; interpret inspection direction, mitigate potential issues, and support accurate and timely information transfer to inspectors.
Plan and manage staffing, budgets, and expenses.
Manage, coach, provide feedback to, and review the work of the team; provide mentorship and professional development.
Drive a culture of quality, accountability, ethical conduct, and continuous improvement.