Senior QA Director Xenotransplantation

United Therapeutics Corporation; Stewartville (MN); Presencial; USD 168.000 - 230.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision, prescription

Employee wellness resources

401k and ESPP

Paid time off & parental leave

Disability benefits

Descripción de la vacante

United Therapeutics Corporation seeks a Director, Quality Assurance – Xenotransplantation to lead QA for designated pathogen‑free animal organs intended for human transplantation. You will ensure regulatory compliance and drive continuous improvements across animal care, laboratories, and manufacturing functions.

You will partner with Site Operations, Regulatory Affairs, and R&D to enable inspection readiness, right‑first‑time execution, and successful FDA approval efforts in a highly novel

Formación

• Bachelor’s 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 leadership and coaching
• Experience managing FDA inspections
• Strong knowledge of GxP, FDA/USDA guidelines, and QA systems
• Excellent written and verbal communication skills
• Ability to lead cross‑department collaborations

Responsabilidades

• Provide strategic and operational QA leadership for Xenotransplantation.
• Ensure compliance with FDA/USDA and GxP across operations.
• Lead audits and inspections; coordinate regulatory readiness.
• Develop QA policies, procedures, and programs for xenotransplantation and organ manufacturing.
• Maintain document control and data integrity across operations and labs.
• Oversee deviations, investigations, CAPAs, change control, and product quality reviews.
• Collaborate with Operations, R&D, Regulatory Affairs to drive improvements.

Conocimientos

Leadership

Problem solving

Communication

Data interpretation

Cross-functional collaboration

Educación

Bachelor’s Degree in science/engineering

Master’s Degree in science/engineering

Herramientas

Microsoft Excel

Microsoft PowerPoint

Microsoft Word

Microsoft Outlook

Descripción del empleo

United Therapeutics Corporation seeks a Director, Quality Assurance – Xenotransplantation to lead QA for designated pathogen‑free animal organs intended for human transplantation. You will ensure regulatory compliance and drive continuous improvements across animal care, laboratories, and manufacturing functions.

You will partner with Site Operations, Regulatory Affairs, and R&D to enable inspection readiness, right‑first‑time execution, and successful FDA approval efforts in a highly novel