Manager, Global GMP Compliance

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.

The Manager, Global GMP Compliance is responsible for managing Quality Management Systems (QMS) and various compliance activities. This role ensures ongoing compliance with current Good Manufacturing Practices (cGMPs), applicable regulatory requirements, and UTC requirements. Key responsibilities include managing and facilitating routine quality data analysis and QMS trending activities; developing, maintaining, and distributing Key Performance Indicator (KPI) dashboards and metrics for executive and site level management review;

coordinating product recall and market action activities; and monitoring and assessing regulatory intelligence to identify emerging compliance risks, industry trends, and regulatory expectations. As an integral member of the Global GMP QMS and Compliance team, this position supports the maintenance and continuous improvement of Quality Management System and compliance processes to ensure ongoing company and product compliance with FDA and other global regulatory agency requirements.

• Lead implementation, maintenance, and continuous improvement of standardized regulatory intelligence process to identify new or changing regulatory requirement to ensure ongoing awareness.
• Facilitate cross‑functional impact assessment on UTC product and process.
• Monitor, assess, and interpret regulatory change and emerging compliance trend; translate insight into actionable recommendation; proactively communicate regulatory intelligence to relevant stakeholder and support informed, risk‑based organizational decision‑making.
• Coordinate product recall process, including planning, execution, documentation, and continuous improvement.
• Maintain recall readiness through periodic mock recall.
• Maintain established key quality performance indicator (KPI) and supporting KPI tool (e.g., Power BI) to develop dashboard and communicate periodic metric report to site management and executive leadership.
• Prepare and deliver training on KPI tool use, report, and dashboard across all sites, as needed.
• Analyze compliance trend and metric, identify risk or gap, and provide clear, data‑driven reporting to management.
• Coordinate corporate level management review activity by compiling, presenting, and interpreting compliance data and effectiveness of quality system control to management.
• Lead assigned Quality Management System improvement initiative, ensuring process align with UTC expectation and applicable regulatory requirement. Track Quality Plan improvement activity and provide status update and progress report.
• Support and manage emerging quality program such as Quality Maturity Index and Quality Risk assessment.
• Monitor and report compliance metric related to Health Authority and/or Notified Body inspection outcome.
• Mana…