Advarra
501 - 1000 employees
Founded 1983
☁️ SaaS
🤖 Artificial Intelligence
Healthcare • SaaS • Artificial Intelligence
Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.
Pharmaceutical Quality GMP Auditor – Consulting
🕒 March 27
🗣️🇯🇵 Japanese Required
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Advarra
501 - 1000 employees
Founded 1983
☁️ SaaS
🤖 Artificial Intelligence
Healthcare • SaaS • Artificial Intelligence
Advarra is a provider of integrated technology and services for clinical research, combining institutional review and compliance services with software platforms to support the full clinical trial lifecycle. The company offers ethics review services (IRB, IBC, DMC, endpoint adjudication), site enablement and research staffing, and a suite of cloud products — including eRegulatory, eConsent, eSource/EDC, CTMS and study design tools — plus an AI-powered operational intelligence engine (Braid) to streamline trial start-up, enrollment, and operations. Advarra serves sponsors, CROs, research sites, and institutions with a focus on patient protection, regulatory compliance, and accelerating trial outcomes.
📋 Description
• Conduct Good Manufacturing Practice (GMP) audits (planning, agenda, physical or remote audit, and report writing) • Evaluate investigator sites, CROs, and vendor compliance or qualification. • Prepare comprehensive audit reports detailing findings and root-causes. • Work collaboratively with clients to ensure quality standards.
🎯 Requirements
• Minimum 10+ years of Clinical Quality Assurance and/or Good Manufacturing Practice (GMP) experience. • Minimum 5+ years of Good Manufacturing Practice (GMP) auditing experience. • B2 level in English communication, verbal and written • B2 level in Japanese communication, verbal and written • Bachelor's degree
🏖️ Benefits
• Remote work options • Comprehensive audit reports detailing findings
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