Senior Manager GD GCP Auditing

Role: Senior Manager in GCP GCP Auditing within Regeneron's Global Development Quality Assurance team, focusing on risk-based auditing to ensure compliance across global clinical activities. Responsibilities: lead end-to-end GCP audits—routine, process, site, vendor, and partner audits; develop audit programs; identify compliance issues; support regulatory inspections; and drive process improvements. Qualifications: Bachelor’s degree with 8+ years of relevant industry experience, including at least 5 years in GCP audit roles; deep knowledge of FDA, EU regulations, ICH guidance, and GCP standards; experience with regulatory inspections and complex GxP compliance issues; strong stakeholder management and leadership skills. High-Value: Clinical development, GCP compliance, regulatory inspections, audit management, cross-functional collaboration. WorkSetup: Remote U.S.; 30-40% domestic and international travel.