Vice President, Quality Operations – Combination Products

Company Overview

United Therapeutics (Nasdaq: UTHR) is the first publicly‑traded biotech or pharmaceutical company organized as a public benefit corporation. Our purpose is to provide a brighter future for patients through novel pharmaceutical therapies and technologies that expand the availability of transplantable organs. Founded in 1996 to address pulmonary arterial hypertension (PAH), we now have six FDA‑approved therapies for PAH, PH‑ILD, and neuroblastoma, and we are advancing additional treatments for PAH and pulmonary fibrosis. We are also developing manufactured organs to eliminate transplant waiting lists.

How You’ll Contribute

• Oversee all Quality functions for Dry Powder Inhalation and Soft Mist Inhaler production facilities, ensuring compliance with global GMP/GDP regulations and United Therapeutics quality standards.
• Provide strategic leadership in regulatory compliance for drug products and medical devices, lead Health Authority interactions, and support operational excellence.
• Lead Quality activities related to facility start‑up, including equipment qualification, process validation, and regulatory filings.
• Manage Health Authority inspections, ensuring audit readiness and successful outcomes.
• Collaborate with Manufacturing to establish effective quality standards that ensure functionality and patient safety.
• Approve GMP documentation such as batch records, deviations, validation protocols, and regulatory filings.
• Build and maintain Quality Agreements with manufacturing vendors and device suppliers.
• Adapt quality systems and procedures to combination product requirements, including design control, risk management, and post‑market surveillance.
• Evaluate quality systems through routine risk assessments and drive corrective and preventive actions (CAPAs) to improve product and process quality.
• Lead cross‑functional technology transfer activities, integrating drug and device components into combination products.
• Drive continuous‑improvement initiatives to enhance manufacturing processes, product quality, and operational efficiency while maintaining compliance.
• Collaborate with supply‑chain teams to ensure uninterrupted product supply meeting the highest quality standards.
• Represent the Quality function in leadership meetings, communicating goals and progress to internal stakeholders and regulatory agencies.
• Monitor and integrate emerging regulatory requirements for combination products, ensuring proactive compliance.
• Develop and maintain training programs for quality staff on combination product regulations, quality systems, and manufacturing processes.
• Partner with Manufacturing, Regulatory Affairs, and Engineering to support scale‑up and ensure regulatory submissions meet global expectations.
• Perform all other duties as required.

Minimum Requirements

• Bachelor’s degree in a scientific discipline (or equivalent experience/training).
• 15+ years of progressive experience in quality aspects of the pharmaceutical or fine chemicals industry.
• 10+ years of management experience, including 5+ years overseeing both QA and QC functions.
• 7+ years of experience with FDA, USP, and EP testing requirements.
• 5+ years of experience in stability testing programs.
• Experience with instrumentation and expertise in HPLC, GC, UV/VIS, FTIR.
• Experience with US FDA, EU, and JP GMP regulations.
• Experience in analytical method development/validation and laboratory method transfer protocols.
• Experience in lab and manufacturing equipment qualification (IQ, OQ, PQ) protocol review, writing, and application.
• Experience in departmental budgeting.
• Advanced working knowledge of cGMPs.
• Exceptional attention to detail and strong organizational skills.
• Effective prioritization for self and team; ability to work independently and collaboratively in a multi‑functional environment.
• Ability to thrive in high‑pressure settings, managing heavy workloads and tight deadlines.
• Advanced proficiency in MS Office, especially Word and Excel.

Preferred Qualifications

• Master’s degree in a scientific discipline (or equivalent experience/training).

Benefits

• Comprehensive medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans including 401(k) and Employee Stock Purchase Plan (ESPP).
• Paid time off and paid parental leave.
• Disability benefits.
• Additional programs and amenities as detailed on the company benefits page.

Location

This position is on‑site 100% at United Therapeutics’ RTP, North Carolina location (ZIP 27713). Relocation assistance may be available for non‑local candidates.