Senior GPS & PV, Quality Control, Compliance & Training Manager

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

Are you a pharmacovigilance professional who is ready to apply your expertise in a new way? We’re looking for someone with a strong foundation in drug safety and pharmacovigilance who is excited to lean further into a role in training, compliance, and quality control.

This role will lead the design, development, and continuous improvement of Global Patient Safety (GPS) training strategies, with a focus on training operations, innovation, effectiveness, and measurable outcomes. This person will partner with GPS functional leadership and peers to ensure training programs are aligned with regulatory requirements, evolving business processes, and innovative learning approaches, and will establish and maintain a robust, data-driven training framework to assess knowledge retention, training effectiveness, and compliance across internal staff, vendors, and partners. In addition to core training responsibilities, this role will provide operational support across Quality Records (e.g., deviations, Corrective and Preventive Actions, Effectiveness Checks, etc.) and Compliance to ensure continuity of Quality, Training, and Compliance (QTC) activities within a lean team structure, and will contribute to inspection readiness, audit support, and continuous improvement initiatives to sustain a compliant and inspection-ready GPS Quality Management System (QMS).
 

Training Operations, Innovation & Effectiveness

• Lead the GPS Training program, including curriculum development, training assignments, training compliance, and document management of key GPS training material ensuring application of adult learning principles to support engagement and knowledge retention
• Lead the end-to-end strategy for GPS training programs, ensuring alignment with global regulatory requirements and internal procedures and adult learning principles that promote practical application and learner-centered design
• Design and implement innovative, scalable, and fit-for-purpose training approaches grounded in adult learning theory (e.g., experiential learning, scenario-based training, spaced reinforcement) to improve knowledge retention and operational performance
• Establish and maintain training effectiveness metrics (e.g., knowledge assessments, trending, inspection readiness indicators) incorporating evaluation of knowledge retention over time and application of learning and report insights to leadership
• Lead training initiatives, such as conducting training needs analyses based on deviations, Corrective and Preventive Actions (CAPAs), audit findings, process changes, and regulatory updates and translating these into targeted, risk-based learning interventions
• Drive continuous improvement of training curricula using industry insights and inspection/audit data, and adult learning methodologies to enhance training impact and sustained competency
• Oversee training compliance for GPS staff, vendors, and partners, including identification and escalation of non-compliance, while ensuring training approaches are effective for diverse adult learner populations
• Lead company-wide adverse event (AE) and serious adverse