Director, Quality Assurance - Xenotransplantation (DPF)

United Therapeutics•Stewartville, MN

2d•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 operations across DPF site operations, animal care, laboratories, and manufacturing functions. As a senior Quality leader for DPF operations, the Director 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 role provides strategic direction and governance for the DPF Quality Management System and leads Quality Assurance efforts supporting regulatory and clinical work toward FDA approval of animal organs for human transplantation. The position is responsible for planning, staffing, budgeting, and managing expenses; leading and developing the team; and fostering a culture of quality, accountability, ethical conduct, and continuous improvement. It is based 100% onsite at the company’s Stewartville, Minnesota facility, requires up to 25% travel, and requires no 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 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 and 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, lead meetings, and deliver presentations.
Ability to review others’ work, identify issues or deficiencies, enforce company policies and procedures, and drive corrective actions.
Ability to handle confidential company data, projects, and information with discretion.
Ability to interpret data in relation to company procedures and current GxP, Quality Systems, USDA, and other requirements.
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

Provide strategic planning, direction, and goal setting 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 continuously improve QA policies, procedures, and programs supporting xenotransplantation and organ manufacturing.
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 QA support for regulatory and clinical efforts toward FDA approval of animal organs for human transplantation.
Review animal care records, analytical and medical records, clinical case records, protocols, reports, environmental monitoring data, and laboratory data for accuracy, completeness, and compliance.
Provide Quality oversight of material receipt, inspection, release, and supplier qualification activities.
Manage controlled-document collaboration, review, and approval.
Provide prompt review of clinical case data.
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 to support annual product reports.
Assist Operations, Quality, and R&D with validation protocols and reports, and coordinate validation plans and tasks for assigned projects.
Develop and provide guidance on new initiatives and quality improvements; assess processes and procedures for efficient resource utilization; and advise senior management and staff.
Establish QA policies, practices, and programs to support the Xenotransplantation function.
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, respond promptly to mitigate potential issues, and support timely and accurate provision of information to inspectors.
Plan, staff, and budget the function and manage expenses.
Manage, coach, provide feedback to, and review the work of the team, while supporting mentorship and professional development.
Drive a culture of quality, accountability, ethical conduct, and continuous improvement.