Senior GPS & PV, Quality Control, Compliance & Training Manager
United Therapeutics Corporation
June 27, 2026
Remote friendly (Raleigh-Durham-Chapel Hill Area)
United States
Operations
Responsibilities:
- Lead design, development, and continuous improvement of Global Patient Safety (GPS) training strategies (training operations, innovation, effectiveness, measurable outcomes).
- Manage GPS Training program: curriculum development, assignments, compliance, and document management using adult learning principles.
- Own end-to-end training strategy aligned to global regulatory requirements and internal procedures.
- Design scalable, fit-for-purpose training (e.g., experiential learning, scenario-based training, spaced reinforcement).
- Establish training effectiveness metrics (knowledge assessments, trending, inspection readiness) and report insights.
- Conduct training needs analyses from deviations, CAPAs, audit findings, process changes, and regulatory updates; deliver risk-based learning interventions.
- Oversee training compliance for GPS staff, vendors, and partners; identify/escalate non-compliance.
- Lead AE/SAE training for commercial and clinical programs.
- Support quality records/QTC operations: deviations, CAPAs, effectiveness checks (as needed), RCA/CAPA development, tracking/trending quality events.
- Support inspection and audit readiness; serve as QTC SME during audits.
- Support governing document harmonization (e.g., SOPs, guidance, templates) and alignment between procedural updates and training.
- Perform other duties as assigned.
Minimum Requirements:
- Bachelor’s (10+ years) or Master’s (8+ years) or PharmD/equivalent (5+ years) in relevant field; pharmacovigilance/drug safety/patient safety experience.
- 5+ years applying global PV regulations/processes (ICSRs, aggregate reporting, signal detection, PVAs, quality systems).
- 3+ years quality systems/quality records (deviations, CAPAs, RCA).
- 3+ years audits/regulatory inspections (inspection readiness, CAPA management).
- Strong adult learning/training innovation, analytical thinking, and ability to translate PV concepts into training.
- Working knowledge of QMS, audit/inspection processes, and Microsoft Office.
Preferred:
- RN; advanced degree; 5+ years PV training/education; LMS experience; experience measuring training effectiveness; modern learning strategy experience.
To Apply:
- Submit resume and cover letter outlining interest in the position.
- Lead design, development, and continuous improvement of Global Patient Safety (GPS) training strategies (training operations, innovation, effectiveness, measurable outcomes).
- Manage GPS Training program: curriculum development, assignments, compliance, and document management using adult learning principles.
- Own end-to-end training strategy aligned to global regulatory requirements and internal procedures.
- Design scalable, fit-for-purpose training (e.g., experiential learning, scenario-based training, spaced reinforcement).
- Establish training effectiveness metrics (knowledge assessments, trending, inspection readiness) and report insights.
- Conduct training needs analyses from deviations, CAPAs, audit findings, process changes, and regulatory updates; deliver risk-based learning interventions.
- Oversee training compliance for GPS staff, vendors, and partners; identify/escalate non-compliance.
- Lead AE/SAE training for commercial and clinical programs.
- Support quality records/QTC operations: deviations, CAPAs, effectiveness checks (as needed), RCA/CAPA development, tracking/trending quality events.
- Support inspection and audit readiness; serve as QTC SME during audits.
- Support governing document harmonization (e.g., SOPs, guidance, templates) and alignment between procedural updates and training.
- Perform other duties as assigned.
Minimum Requirements:
- Bachelor’s (10+ years) or Master’s (8+ years) or PharmD/equivalent (5+ years) in relevant field; pharmacovigilance/drug safety/patient safety experience.
- 5+ years applying global PV regulations/processes (ICSRs, aggregate reporting, signal detection, PVAs, quality systems).
- 3+ years quality systems/quality records (deviations, CAPAs, RCA).
- 3+ years audits/regulatory inspections (inspection readiness, CAPA management).
- Strong adult learning/training innovation, analytical thinking, and ability to translate PV concepts into training.
- Working knowledge of QMS, audit/inspection processes, and Microsoft Office.
Preferred:
- RN; advanced degree; 5+ years PV training/education; LMS experience; experience measuring training effectiveness; modern learning strategy experience.
To Apply:
- Submit resume and cover letter outlining interest in the position.