Director, Quality Assurance - Xenotransplantation (DPF)

United Therapeutics Corporation•Christiansburg, VA

18h•Onsite

About The Position

United Therapeutics is the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation, focused on developing novel pharmaceutical therapies and technologies to expand the availability of transplantable organs. Founded in 1996, the company has six FDA-approved therapies for PAH, PH-ILD, and neuroblastoma, and a near-term pipeline for PAH and pulmonary fibrosis. A significant part of their mission involves creating manufactured organs (kidneys, hearts, lungs, livers) to address the shortage of transplantable organs and eliminate waiting lists. The Director, Quality Assurance – Xenotransplantation will provide strategic leadership and hands-on quality oversight for the manufacture and release of designated pathogen-free (DPF) animal organs intended for human transplantation. This role operates at the intersection of FDA, USDA, and global GxP expectations in a novel environment, ensuring sustained compliance and enabling operational execution across DPF site operations, animal care, laboratories, and manufacturing functions. The position serves as a senior Quality leader, partnering 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 highly regulated and novel manufacturing environment.

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

Responsible for strategic planning, direction, and goal setting for the Quality Assurance function of Xenotransplantation
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