Director, Quality Assurance - Xenotransplantation, Designated Pathogen-Free

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The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.
 

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).
 

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

You’ll help define what “right first time” means in one of the most ambitious frontiers of modern medicine. In this role, you’ll provide both strategic leadership and hands‑on quality oversight for the manufacture and release of designated pathogen‑free animal organs intended for human transplantation—operating at the intersection of FDA, USDA, and global GxP expectations in a truly novel environment. This is a role for a quality leader who thrives on complexity, builds systems that people actually follow, and wants their expertise to directly shape the future of organ transplantation.

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. This role ensures sustained compliance with FDA, USDA, and global GxP requirements while enabling operational execution across DPF site operations, animal care, laboratories, and manufacturing functions. This position serves 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 in a highly regulated and novel manufacturing environment.
 

• 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

Minimum 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
• 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

Preferred Qualifications

• 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

Job Location

This position will be based 100% onsite at our facility in Stewartville, MN and will require up to 25% travel.

The salary range for this position is $167,500 - $230,000 per year and reflects our good-faith estimate of the compensation for this role at the time of posting. An employee’s position within the salary range will be based on factors such as education, qualifications, experience, skills, geographic location, and business needs, as well as other factors permitted by law at the time of posting. This range may be modified in the future based on company and market factors.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.