Manager, GMP Supplier Quality Management

Who You Are

This role is responsible for establishing, maintaining, and continuously improving the Supplier Quality program for all United Therapeutics sites. Own quality oversight of assigned suppliers from onboarding through ongoing performance monitoring to disengagement; serve as primary quality contact for internal stakeholders.

• Manage Supplier Quality Management program aligned with FDA QMSR and 21 CFR Part 4.
• Execute risk-based supplier qualification, approval, requalification, and disqualification (suppliers, contract manufacturers/labs, distributors, service providers, critical material vendors) with GMP Auditing.
• Perform GxP Vendor List risk assessments to build the annual vendor audit schedule.
• Negotiate and maintain supplier Technical/Quality Agreements (quality, compliance, notification, change control, documentation).
• Develop vendor KPIs/scorecards; monitor performance via metrics, trends, management review inputs, and escalation.
• Support investigations and CAPA for deviations/nonconformance, OOS events.
• Coordinate vendor change notifications; assess impacts to product quality, regulatory filings, validated processes, specs, labeling, and supply continuity.
• Escalate vendor quality issues (material holds, corrective actions, field impact, recall/regulatory inspection support).
• Drive continuous improvement to reduce quality events and improve Right First-Time (RFT).
• Maintain vendor-management records; author/revise vendor quality procedures and training.

• 8+ years QA with a Bachelor’s (or 6+ with Master’s, or 2+ with PhD/PharmD)
• 5+ years vendor oversight; 2+ years people management
• Strong technical/regulatory knowledge (cGMP; 21 CFR 210/211; FDA QMSR; ISO 13485; ISO 14971; EU MDR; ICH)
• Experience with supplier qualification, risk management, quality agreements, audits, performance monitoring
• Excellent written/verbal communication.

• ASQ Certified Quality Auditor and/or CQM
• MS Office, Docu Sign, electronic QMS; AI applications knowledge
• Strong organization, cross-functional leadership/influence, attention to detail.

• medical/dental/vision/prescription coverage, wellness resources, 401k/ESPP, paid time off/paid parental leave, disability benefits and more.