Director, Quality Assurance - Xenotransplantation (DPF)

United Therapeutics•Christiansburg, VA

14h•Onsite

About The Position

United Therapeutics is a public benefit corporation focused on developing novel pharmaceutical therapies and technologies to expand the availability of transplantable organs. The company aims to treat rare, deadly diseases and address the shortage of transplantable organs by creating manufactured organs. This role is for a quality leader who will provide strategic leadership and hands-on quality oversight for the manufacture and release of designated pathogen-free animal organs intended for human transplantation. The position operates at the intersection of FDA, USDA, and global GxP expectations in a novel environment, requiring a leader who thrives on complexity, builds effective systems, and wants to shape the future of organ transplantation.

Requirements

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
Ability to handle confidential company data, projects, information, etc.
Proficiency with Microsoft Excel, PowerPoint, Word, and Outlook
This position requires working in-person from our 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 environment
Experience with TrackWise and MasterControl (eDMS) systems
Working knowledge of Laboratory Information Management Systems (LIMS)
Experience with SAP S/4HANA

Responsibilities

Provide 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.
Ensure sustained compliance with FDA, USDA, and global GxP requirements while enabling operational execution across DPF site operations, animal care, laboratories, and manufacturing functions.
Serve as a senior Quality leader for DPF operations, partnering closely with Site Operations, Animal Care, Facilities, Supply Chain, Regulatory Affairs, and R&D to drive inspection readiness, right‑first‑time execution, and continuous improvement.
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.
Lead Quality Assurance to support regulatory and clinical efforts to reach FDA approval of animal organs for human transplant.
Review documentation (including, but not limited to: animal care records, analytical/medical records, clinical case records, protocols, reports, environmental monitoring data, and laboratory data) for accuracy, completeness, and compliance with United Therapeutics policies and procedures, and GxP/FDA/Clinical Trial/USDA requirements.
Provide Quality oversight of material receipt, inspection, release, and supplier qualification activities.
Manage and lead controlled document collaboration, review, and approval.
Provide prompt review of clinical case data.
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.
Perform internal and vendor audits; track corrections to audit observations and manage internal and external audit files; summarize data to support annual product reports.
Assist Operations, Quality, and R&D in the preparation of validation protocols and reports; coordinate validation plans and tasks to ensure timely completion of validation projects as assigned by Quality management.
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.
Establish Quality Assurance policies, practices, and programs to support Xenotransplantation function.
Initiate and lead departmental and/or interdepartmental strategic objectives; translates 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.
Responsible for overall planning, staffing, budgeting, and managing expenses.
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.
All other duties as required.