Senior Manager, Clinical Study Quality Lead

Role: Senior Manager, Clinical Study Quality Lead, providing GCP QA oversight for clinical trials to ensure compliance with GCP, global regulations, and study protocols. Responsibilities: partner with clinical teams, CROs, vendors, and investigator sites to conduct risk-based quality reviews, develop audit plans, support inspection readiness, and investigate quality issues; review study documentation, monitor compliance data, and contribute to process improvements. Requirements: Bachelor’s degree and 6+ years of direct GCP QA experience supporting clinical trials in a sponsor, CRO, or regulated environment; strong knowledge of ICH GCP E6(R3) and global trial regulations; experience with clinical development in drugs or biologics. Preferred: experience with device, cell/gene therapy trials, Phase 1 sites, and professional certifications like RQAP-GCP or CCRP. High-Value: clinical trial oversight, GCP audit support, inspection readiness, risk management, biologics/drugs, global regulation compliance, and cross-functional stakeholder engagement. Work setup: hybrid or on-site; up to 10% travel.