Director, Quality Assurance - Xenotransplantation (DPF)

United Therapeutics Corporation•Stewartville, MN

3d•$167,500 - $230,000•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 supporting DPF site operations, animal care, laboratories, and manufacturing functions. It partners with Site Operations, Animal Care, Facilities, Supply Chain, Regulatory Affairs, and R&D to advance inspection readiness, right-first-time execution, and continuous improvement in a novel manufacturing environment. The position leads strategic planning, governance, and continuous improvement of the DPF Quality Management System and QA function. It oversees quality systems and records, supports regulatory and clinical efforts toward FDA approval of animal organs for human transplant, and provides quality oversight across documentation, materials, suppliers, audits, validations, and product quality activities. The Director also leads regulatory inspections and is accountable for departmental planning, staffing, budgeting, team development, and fostering a culture of quality, accountability, ethical conduct, and continuous improvement. This position is based 100% onsite at the company’s facility in Stewartville, Minnesota, requires up to 25% travel, and requires in-person work five days per week when not traveling. The employee must not have interaction with pigs outside the company.

Requirements

Bachelor’s or master’s degree in science, engineering, or a related field.
15 or more 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 QA 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 procedures, processes, and products, including organ assessment and preservation.
Strong analytical judgment and exceptional problem-solving and risk-assessment capabilities.
Strong written and verbal communication skills, including professional documentation and independently producing high-volume, complex written materials.
Ability to work 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 facilities five days per week when not on business travel.
Must not have interaction with pigs outside of the company.

Nice To Haves

12 or more years of experience in an 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

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 quality standards.
Establish, maintain, and improve QA policies, procedures, and programs supporting xenotransplantation and organ manufacturing.
Oversee deviations, investigations, CAPAs, change control, complaints, and product quality reviews.
Ensure effective document control, data integrity, and record retention across animal care, laboratories, and manufacturing operations.
Lead QA support for regulatory and clinical efforts toward FDA approval of animal organs for human transplant.
Review animal care, analytical and medical records, clinical case records, protocols, reports, environmental monitoring data, and laboratory data for accuracy, completeness, and compliance.
Oversee material receipt, inspection, release, and supplier qualification activities.
Manage controlled-document collaboration, review, and approval; promptly review clinical case data.
Perform QA oversight to ensure compliance with regulatory standards, including oversight of investigations, change control, complaints, SOPs, and product quality reviews.
Review and write or update SOPs and reports supporting quality systems.
Perform internal and vendor audits, track corrections to audit observations, manage audit files, and summarize data for annual product reports.
Assist Operations, Quality, and R&D with validation protocols and reports; coordinate validation plans and tasks to complete assigned projects on time.
Develop guidance for initiatives and quality improvements, assess processes and procedures for efficient resource use, and advise senior management and staff.
Initiate and lead departmental or interdepartmental strategic objectives and translate strategy into operational and tactical plans.
Lead FDA, USDA, and other regulatory agency inspections; interpret inspection direction, respond promptly to mitigate potential problems, and support accurate and timely transfer of information 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.
Promote a culture of quality, accountability, ethical conduct, and continuous improvement.