Senior QA Engineer

California, US residents .

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.

Ready to bring your quality expertise to therapies that change lives? As our next Senior Quality Engineer, you’ll help shape the future of new APIs, drug products, and combination products—from development through commercialization—while keeping our marketed products performing at their best. You’ll lead investigations (OOS, CAPAs, change controls, exceptional conditions), approve critical GMP documentation (IOQ/PQ, process and method validations, stability protocols), and serve as a trusted on‑site partner to CMC and our CMOs.

You’ll be a steady, strategic presence during FDA, MHRA, and partner inspections, and a go‑to SME when complex quality challenges land on the table. If you’re a sharp problem‑solver who thrives on ownership, collaboration, and continuous improvement—this is where your work makes a real difference.

The Senior Quality Engineer will support the development of new active ingredients, drug products, and combination products through the design and development, implementation of process verification and validation activities and commercialization, including maintenance and improvement of currently marketed products. Responsible for implementation of standards, methods, and procedures for product development.

• Collaborate and approve GMP related documents (i.e. IOQ and PQ documents, process validation protocols, analytical/microbiological method validations, stability protocols, operational protocols and reports, etc.) pertaining to chemical intermediates APIs and drug products for accuracy, completeness, and compliance with UT policies, procedures, and cGMPs
• Lead or collaborate on investigations for quality events, investigations, out of specifications (OOS), change controls, exceptional conditions, and corrective and preventive action (CAPA) processes for cGMP events
• Create or assist in the creation of batch records, protocols, summary reports, standard operating procedures, raw material specifications, etc.
• Provide QA Engineering input to process and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested
• Participate in project initiatives, project start‑up, and continuous process verification
• Serve as an on‑site contact for CMC personnel
• Support maintenance of Quality Agreements with suppliers and contract manufacturing organizations
• Support QE management during regulatory agency inspections (FDA, MHRA, etc.) and participate in the closure of internal and regulatory audit observations
• Oversee CMO related manufacturing processes, change controls, investigations, and new projects. Perform “in‑plant”…