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 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 arterialhypertension (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.
The Vice President, Quality Operations - Combination Products will oversee all Quality functions associated with United Therapeutics' Dry Powder Inhalation and Soft Mist Inhaler production facilities. These facilities will manufacture, label and package finished drug product and medical devices. This functional site head role ensures these products meet global GMP/GDP regulations, UT quality standards, will drive compliance and will foster a culture continuous improvement. The VP position will provide strategic leadership in regulatory compliance for these drug products and medical devices, lead Health Authority interactions, and support collaboration to achieve operational excellence.
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 numerous 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
All other duties as required
Minimum Requirements:
Preferred Qualifications:
Job Location:
United Therapeutics requires this candidate to be on-site 100% of the time at our RTP, North Carolina location in zipcode 27713. Relocation assistance may be available for non-local candidates.