Senior Manager, Clinical Study Quality Lead (Hybrid)

Role: Senior Manager, Clinical Study Quality Lead, providing GCP quality oversight for Vertex's clinical trials to ensure compliance with GCP, regulations, and protocols. Responsibilities: serve as the study-level quality lead, conduct risk-based reviews of study documentation, support audit planning and execution, manage CAPA and quality issues, monitor compliance data and trends, and contribute to inspection readiness and process improvements. Requirements: Bachelor's degree, 6+ years of direct GCP QA experience in clinical trials (sponsor, CRO, or regulated environment), strong knowledge of ICH GCP E6(R3) and global regulations, experience supporting drugs and biologics. Preferred: experience with devices, cell/gene therapies, Phase 1 GCP activities, and professional certifications (e.g., RQAP-GCP, CCRP). High-Value: clinical trial QA in biopharma, including audits, inspection support, risk management, and oversight of investigator sites; eligible for hybrid or on-site work with up to 10% travel.