Director, Quality Assurance - Xenotransplantation (DPF)

California, US residents click here.

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