QA/QC Manager - DPF

About Us

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 develop treatments for rare, deadly diseases. Founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH), we now have six FDA-approved therapies treating PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD), and neuroblastoma, a rare pediatric cancer. Our near-term pipeline focuses on additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases is often an organ transplant, but only a small percentage of donated organs are available. We are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers, aiming to eliminate the transplant waiting list and cure end-stage organ diseases.

About the Role

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.

Responsibilities

• 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.

Requirements

• 8+ years of experience in a GMP/QSR regulated environment with a Bachelor's Degree or 6+ years of experience 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 and 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.

Benefits

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including:

• Medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans (401k and ESPP).
• Paid time off and paid parental leave benefits.
• Disability benefits.

For additional information on Company benefits, visit https://www.unither.com/careers/benefits-and-amenities.