Auditor II, Global GMP/GDP Audits & Compliance (Candidates local to RTP or Silver Spring ONLY)

Role: Auditor II responsible for ensuring quality systems compliance at United Therapeutics' sites and GMP/GDP vendors through internal audits, vendor assessments, and regulatory support. Key responsibilities include conducting audits of manufacturing, packaging, analytical processes, and facilities; developing risk-based audit plans; managing vendor qualification and change notifications; and supporting quality improvement initiatives. The role involves close interaction with external suppliers, internal departments, and regulatory bodies, with a focus on maintaining cGMP compliance for biologics, sterile products, and device manufacturing from development through commercialization. Requirements: Bachelor's in science or engineering, 5+ years in FDA-regulated industry auditing or supplier management, strong knowledge of cGMP regulations (21 CFR Parts 210-211, 11, QMSR), and excellent communication skills. Preferred qualifications include Master's or PhD, ASQ or ISO lead auditor certification, experience in sterile and biologic manufacturing, and familiarity with electronic QMS systems. The position is based near RTP, NC, or Silver Spring, MD, with up to 50% travel including some international. The salary range is $88,000-$135,000, depending on experience and qualifications.