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

Pharmacovigilance Training Operations, Innovation & Effectiveness Lead

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 are 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).

Minimum Requirements:

• Bachelor's Degree in nursing, pharmacy, life sciences, or a related healthcare/scientific discipline, and 10+ years of experience in pharmacovigilance, drug safety, or patient safety within the biotechnology, or pharmaceutical industry, or Master's Degree in a scientific, healthcare, or education-related discipline (e.g. public health, clinical education, instructional design), and 8+ years of experience in pharmacovigilance, drug safety, or patient safety within the biotechnology or pharmaceutical industry, or PharmD, or equivalent healthcare professional qualification, and 5+ years of experience in pharmacovigilance, drug safety, or patient safety within the biotechnology or pharmaceutical industry
• 5+ years of experience applying global pharmacovigilance regulations and processes (e.g., Individual Case Safety Reports [ICSRs], aggregate reporting, signal detection, Pharmacovigilance Agreements [PVAs], quality systems)
• 3+ years of experience supporting quality systems and quality records (e.g., deviations, Corrective and Preventive Actions [CAPAs], root cause analysis [RCA])
• 3+ years of experience supporting audits and regulatory inspections, including inspection readiness and CAPA management

Preferred Qualifications:

• Registered Nurse (RN)
• Master's Degree in a scientific, healthcare, or education-related discipline (e.g., public health, clinical education, instructional design), or Doctor of Pharmacy (PharmD) /RPh, or equivalent healthcare professional qualification
• 5+ years of experience in pharmacovigilance training, education, or capability development (e.g., curriculum design, training delivery, training program oversight, and application of adult learning principles to enhance engagement and knowledge retention)

This role is based in our Durham, NC office. Currently this job is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs.