Vice President, Quality Operations, Dry Powder Inhalation (DPI) and Soft Mist Inhaler (SMI)

California, US residents click here. 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 ideal candidate for the Vice President, Quality Operations, Dry Powder Inhalation (DPI) and Soft Mist Inhaler (SMI) role is a strategic and results-driven leader with deep expertise in quality assurance and regulatory compliance for drug products and medical devices. This individual will play a pivotal role in establishing and overseeing new manufacturing facilities dedicated to DPI and SMI production, ensuring that all quality operations align with global GMP/GDP standards, as well as United Therapeutics' commitment to excellence. As these operations are new to the organization, the VP will be instrumental in leading facility start-up activities, while proactively shaping quality systems to support long-term success. They will manage Health Authority interactions, ensuring audit readiness and seamless regulatory compliance, while fostering a culture of continuous improvement and operational efficiency. This leader must be highly collaborative, working cross-functionally with Manufacturing, Regulatory Affairs, and Supply Chain teams to build a strong quality foundation that supports both commercial production and future growth. With experience in combination products, risk management, and post-market surveillance, the right candidate will drive innovation, implement best-in-class quality standards, and ensure the successful integration of these new operations into the company’s broader manufacturing network. Minimum Requirements Bachelor’s Degree in scientific discipline with equivalent experience/training 15 years of experience with progressive increases in responsibility in quality aspects of the pharmaceutical 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 in instrumentation and expertise in HPLC, GC, UV/VIS, FTIR Experience in 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 Preferred Qualifications Master’s Degree in scientific discipline with equivalent experience/training Job Location United Therapeutics requires this candidate to live near our Durham, North Carolina office. This position will require up to 10% travel. Relocation assistance is available as required. 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 While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients. United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / 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.