Manager-Quality Assurance Auditor- GCP
Indianapolis, Hamilton County, Indiana, 46262, USA
Listed on 2026-10-09
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Manager, GCP Auditing within Regeneron's Global Development Quality Assurance team, responsible for leading risk-based GCP audits across investigator sites, vendors, and internal processes globally.
Primary objective s include ensuring clinical studies meet GCP compliance standards, supporting regulatory inspections, and developing audit strategies.
Responsibilities encompass end-to-end audit management, interpreting FDA, EU, and ICH regulations, and collaborating with cross-functional teams.
Requirements:
Bachelor's degree with over 6 years of industry experience, including at least 4 years in GCP auditing; strong knowledge of FDA, EU regulations, and ICH E6 R3; demonstrated project and stakeholder management skills.
Preferred:
Experience in risk-based clinical audit strategy development and supporting complex compliance projects.
High-Value:
Clinical development audits supporting biopharma trials, with a focus on global regulatory standards, on-site and remote work, and 30-40% travel.
Work setup:
Remote, with significant travel.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).