Director, Quality Assurance - Xenotransplantation (DPF)
United Therapeutics Corporation
June 27, 2026
On-site
Christiansburg, VA
Operations
Responsibilities:
- Provide strategic planning, direction, and goal setting for Xenotransplantation Quality Assurance.
- Govern and ensure compliance of the DPF Quality Management System (QMS) with cGMP/cGLP/cGCP (as applicable), FDA, USDA, and internal standards.
- Establish and continuously improve QA policies, procedures, and programs.
- Own quality oversight for deviations, investigations, CAPAs, change control, complaints, and product quality reviews.
- Ensure document control, data integrity, and record retention across animal care, labs, and manufacturing.
- Lead QA to support regulatory/clinical efforts toward FDA approval for animal organs.
- Review relevant records/data for accuracy, completeness, and compliance with GxP/FDA/Clinical Trial/USDA requirements.
- Oversee material receipt, inspection, release, and supplier qualification.
- Manage controlled document collaboration/approval; perform audits; track audit corrections and maintain audit files.
- Support validation protocol/report preparation and execution.
- Lead/prepare for FDA/USDA (or other) inspections; interpret and respond to findings.
- Plan staffing/budget; coach/mentor the team; drive a culture of quality, accountability, and continuous improvement.
Minimum Requirements:
- BS in science/engineering (or MS).
- 15+ years in a GxP/FDA/USDA-regulated environment.
- QA leadership with QMS/GxP expertise; experience managing FDA inspections.
- Strong analytical judgment, risk assessment, and problem-solving.
- Excellent written/verbal communication; cross-department collaboration.
- Proficient with Microsoft Excel/PowerPoint/Word/Outlook.
- In-person 5 days/week; no interaction with pigs outside the company.
Preferred Qualifications:
- 12+ years in animal husbandry/tissue bank and/or cell processing.
- TrackWise/MasterControl (eDMS), LIMS, SAP S/4HANA.
Location/Compensation:
- 100% onsite in Christiansburg, VA; up to 25% travel.
- Salary range: $167,500–$230,000/year.
Benefits:
- Eligible for medical/dental/vision/prescription, wellness resources, 401k/ESPP, paid time off/paid parental leave, disability benefits, and more.
- Provide strategic planning, direction, and goal setting for Xenotransplantation Quality Assurance.
- Govern and ensure compliance of the DPF Quality Management System (QMS) with cGMP/cGLP/cGCP (as applicable), FDA, USDA, and internal standards.
- Establish and continuously improve QA policies, procedures, and programs.
- Own quality oversight for deviations, investigations, CAPAs, change control, complaints, and product quality reviews.
- Ensure document control, data integrity, and record retention across animal care, labs, and manufacturing.
- Lead QA to support regulatory/clinical efforts toward FDA approval for animal organs.
- Review relevant records/data for accuracy, completeness, and compliance with GxP/FDA/Clinical Trial/USDA requirements.
- Oversee material receipt, inspection, release, and supplier qualification.
- Manage controlled document collaboration/approval; perform audits; track audit corrections and maintain audit files.
- Support validation protocol/report preparation and execution.
- Lead/prepare for FDA/USDA (or other) inspections; interpret and respond to findings.
- Plan staffing/budget; coach/mentor the team; drive a culture of quality, accountability, and continuous improvement.
Minimum Requirements:
- BS in science/engineering (or MS).
- 15+ years in a GxP/FDA/USDA-regulated environment.
- QA leadership with QMS/GxP expertise; experience managing FDA inspections.
- Strong analytical judgment, risk assessment, and problem-solving.
- Excellent written/verbal communication; cross-department collaboration.
- Proficient with Microsoft Excel/PowerPoint/Word/Outlook.
- In-person 5 days/week; no interaction with pigs outside the company.
Preferred Qualifications:
- 12+ years in animal husbandry/tissue bank and/or cell processing.
- TrackWise/MasterControl (eDMS), LIMS, SAP S/4HANA.
Location/Compensation:
- 100% onsite in Christiansburg, VA; up to 25% travel.
- Salary range: $167,500–$230,000/year.
Benefits:
- Eligible for medical/dental/vision/prescription, wellness resources, 401k/ESPP, paid time off/paid parental leave, disability benefits, and more.