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United Therapeutics

QA/QC Manager - DPF

Christiansburg, VA, United States

Apply on usnlx.com About employer

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Job details

Posting language: English
Posted: Jul 25, 2026

Original job description

On-Site

Christiansburg, VA

Full time

R05187

California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .

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

The QA/QC Manager provides operational and tactical leadership for the on-site Quality Assurance and Quality Control Microbiology function at the Designated Pathogen-Free (DPF) Facility in support of xenotransplantation organ manufacturing. This position is responsible for governing the environmental monitoring program at the site, leading deviation and CAPA management for the microbiology and on-site QA functions.

Manage Quality Assurance/Quality Control programs to support regulatory and clinical efforts aimed at achieving FDA approval for advanced therapeutic products
Provide operational leadership for the on-site QA / QC microbiology function at the DPF, including environmental monitoring, microbiological testing, on-site QA oversight, and inspection readiness
Govern the environmental monitoring program for barrier and non-barrier areas of the DPF, including program design review, qualification, periodic trending, signal detection, and continuous improvement
Serve as a senior QA approver of controlled documents in MasterControl and quality records in TrackWise
Lead or oversee root cause analysis for microbiological and environmental events; drive timely CAPA execution and effectiveness verification under risk-based prioritization
Partner with Site Operations, Animal Care, and Facilities to align microbiology and EM controls with operational reality and risk; provide Quality input on facility, process, and equipment changes
Establish operational metrics and dashboards for the QA / QC microbiology function; report performance, risks, and trends to senior Quality leadership on a recurring cadence
Drive supplier qualification activities for critical microbiological consumables, media, reagents, and contract test laboratories; support supplier audit programs as needed
Support strategic initiatives related to the DPF Quality Management System (QMS), inspection readiness, right-first-time execution, and continuous improvement
Act as QA representative in product development meetings, technology transfer, and scale-up activities
Perform internal and vendor audits; track corrective actions and manage audit files; summarize data for annual product reports
Conduct QA oversight activities, including deviation/failure investigations, change control documentation, complaints, SOPs, and product quality reviews
Lead risk assessments and Corrective and Preventive Action (CAPA) programs to proactively address quality issues and prevent recurrence
Lead controlled document collaboration, review, and approval within the electronic document management system
Establish and track key quality indicators (KPIs); present trends and risk analysis to senior leadership
Provide real-time review of clinical case data, which may require procedure and data review outside of normal business hours
Support Operations, Quality, and R&D in preparing validation protocols and reports; coordinate validation plans and tasks to ensure timely completion of projects
Develop and provide guidance on new initiatives and quality improvements; assess internal processes for efficiency
Assist management during FDA or other regulatory inspections; interpret inspection direction and respond quickly to mitigate potential issues; support timely and accurate data/document transfer to inspectors; act with discretion

Minimum Requirements

8+ years of experience in a GMP/QSR regulated environment with a Bachelor's Degree or
6+ years of experience in a GMP/QSR regulated environment with a Master's Degree
Applied knowledge of GMP/QSR, FDA regulations, GxP principles, and industry standards, with the ability to apply requirements to company-specific processes, products, and preservation of lungs
Demonstrated applied expertise in cGMP requirements, environmental monitoring program governance, and QC microbiology operations
Experience supporting regulatory inspections (FDA, USDA, and other agencies) as a subject matter expert
Direct experience reviewing and approving controlled documents, deviations, CAPAs, change controls, and quality records within electronic quality systems
Experience leading root cause analysis for microbiological and environmental events; familiarity with risk-based decision-making (e.g., ICH Q9 principles)
Strong analytical judgment with exceptional problem-solving and risk assessment capabilities
Ability to interpret data and apply GxP principles to xenotransplantation-specific procedures, processes, and products
Experience in review/audit of medical & Quality records
Exceptional skills in problem and risk analysis/assessments
Ability to review work performed by other personnel, communicate problems and deficiencies, elicit corrections, and enforce company policy and procedures
Expertise in preparing for and managing FDA, EMA, and ISO audits

Preferred Qualifications

Ability to lead organizational change related to quality systems and compliance
Experience contributing to IND, IDE, or BLA submissions
Experience with TrackWise and MasterControl (eDMS)
Experience creating and implementing a QMS

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.

We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success.

We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work.

Apply on usnlx.com About employer

More about this job

Skills

Leadership
Quality assurance
Quality control
Manage quality
Inspection
Process improvement
MasterControl
Root cause analysis
Prioritization
Quality assurance procedures
Arrange audit
Documentation
Collaboration
Document management
Good manufacturing practices
Quality control systems
Decision making
Problem solving
Hazard assessment
Manage quantitative data
Regulatory compliance
IDE
EDMS

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Work requirements

Jobs in the United States