Quality Assurance (QA) Associate
Core
Facilitate management of sponsor audits and regulatory inspections (FDA, EMA, MHRA) while managing QA relationships with external clients.
Role type
Quality Assurance Associate (Regulatory Inspections)
Builds
Inspection readiness activities and audit support for Medpace study teams and external clients
Domain
Clinical Research / Biopharmaceuticals
Deliverable
client delivery
Required skills
Regulatory inspection management, audit facilitation, QMS clarity, inspection data analysis, training management, site readiness assessment, QA lead coordination
Preferred skills
Experience with FDA/MHRA/EMA inspections, audit support experience
Technologies
Computerized systems
Responsibilities
Facilitate Medpace sponsor audits onsite; Review and assess responses to sponsor audit reports; Provide clarity to the Quality Management System (QMS) during audits; Manage pre-inspection activities; Provide inspection data trends to executive management; Manage the inspection backroom; Conduct mock interviews for SMEs; Review and analyze regulatory inspection data; Manage training for inspection readiness; Conduct inspection readiness visits at sites; Act as QA lead for inspections; Maintain FAQ repository for regulatory inspection
Seniority
Individual Contributor
