Vice President, Quality Operations – Combination Products

United Therapeutics (Nasdaq: UTHR) is the first publicly‑traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our purpose is to provide a brighter future for patients through novel pharmaceutical therapies and technologies for transplantable organs. We were founded in 1996 to cure a daughter’s pulmonary arterial hypertension and now have six FDA‑approved therapies that treat PAH, PH‑ILD, and neuroblastoma.

Our near‑term pipeline focuses on therapies for PAH and pulmonary fibrosis. In parallel, we are working to create manufactured organs to address the shortage of donor kidneys, hearts, lungs, and livers.

• Oversee Quality Operations, ensuring all aspects of drug product and medical device manufacturing, labeling and packaging comply with GMP/GDP and applicable global regulatory standards.
• Provide quality leadership in drug product and medical device manufacturing and packaging activities to facilitate timely product disposition.
• Ensure compliance with FDA and other applicable global regulations for drug products and medical devices.
• Lead Quality activities related to the facility start‑up, including equipment qualification, process validation, and regulatory filings.
• Manage Health Authority inspections for the facilities, ensuring audit readiness and successful outcomes.
• Collaborate with Manufacturing teams to establish effective quality standards, ensuring functionality and patient safety.
• Oversee and approve GMP documentation, including batch records, deviations, validation protocols, and regulatory filings.
• Build and maintain Quality Agreements with multiple manufacturing vendors and device suppliers supporting the production of drug products.
• Adapt existing quality systems and procedures to current combination product requirements, including design control, risk management, and post‑market surveillance.
• Evaluate quality systems through routine risk assessments and drive the implementation of corrective and preventive actions (CAPAs) to improve product and process quality.
• Lead cross‑functional teams in technology transfer activities, ensuring seamless integration of drug and device components into a combination product.
• Drive continuous improvement initiatives to enhance manufacturing processes, product quality, and operational efficiency while maintaining compliance.
• Collaborate with supply chain teams to ensure the uninterrupted supply of products, 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 the organization remains compliant and proactive in adapting to changes.
• Develop and maintain training programs to ensure quality staff are proficient in combination product regulations, quality systems, and manufacturing processes.
• Partner with Manufacturing, Regulatory Affairs, and Engineering to support manufacturing scale‑up and ensure regulatory submissions meet global expectations.
• Perform all other duties as required.

• Bachelor’s Degree in a scientific discipline with equivalent experience/training.
• 15+ years of experience with progressive increases in responsibility in quality aspects of the pharmaceutical or fine chemicals industry.
• 10+ years of management experience, inclusive of 5+ years overseeing both QA and QC functions.
• 7+ years of experience in 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 lab 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.
• Demonstrates exceptional attention to detail.
• Exhibits strong organizational skills.
• Effective in prioritizing tasks for self and a team.
• Can work independently and collaboratively within a…