Associate Director, QA Engineering - Combo Products

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.

You bring a wealth of Quality Assurance knowledge to the table and are eager to build and grow a QA team around you. You're able to pivot at a moment's notice between utilizing your individual expertise and mentoring or developing a member of your team. The Associate Director, QA Engineering will provide advanced support and subject matter technical expertise and utilize industry best practices to maintain cGMP compliance for UTC combination products, clinical materials supply, and new product development of active pharmaceutical ingredients (API), drug substances, drug products, and combination product/medical devices.

This role will manage and support the new product development activities through product and process development and improvement, implementation of product/process verification, validation activities, and commercialization. Responsibilities for this role also include oversight and leadership of the Change Control, Quality Event, and CAPA programs and supporting management during regulatory agency(ies) inspections, third‑party partners, and customer audits.

• Work independently and as part of a multi‑functional team to manage, lead, and prioritize workloads, complex projects/tasks, departmental initiatives, and deadlines
• Manage quality engineering input and provide advanced technical expertise to processes and manufacturing documentation, including complex data analysis, material specifications, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested and that compliance to quality systems procedures, regulations, and standards are achieved
• Support the trending and reporting of CAPA activities. Lead investigations and serve as an internal expert for Risk Assessments, Quality Events, Investigations, Out of Specifications (OOS), Change Controls, Exceptional Conditions, and Corrective and Preventive Action (CAPA) processes for GxP events
• Interact regularly with peers and senior management across multiple functional groups (e.g., Research and Development, Manufacturing, Validation, Regulatory Affairs, etc.). Negotiate and manage expectations across functional groups for project timelines and quality requirements
• Lead and manage quality engineering activities and provide SME support for project start‑up and the technology transfer of new products or methods into existing manufacturing operations. Responsible for evaluating new technologies against applicable guidance, and industry practices
• Provide support during external, internal, and health agency audits
• Author, collaborate, analyze, and approve cGxP related documents (i.e., product/ design specifications,…