Manager, Computer Systems Validation (CSV)

Role: Manage and ensure the validation, compliance, and ongoing support of Corcept’s GXP validated systems within the Quality Systems Technology team. Responsibilities: oversee validation activities for pharmaceutical systems, develop validation strategies and documentation (e.g., validation master plans, protocols, reports), support data migration and system changes, coordinate validation projects with external vendors and cross-functional teams, and act as the IT interface with QA for compliance risks and validation deliverables. Requirements: 8+ years in QA or validation within pharma/biotech, with strong knowledge of industry standards including 21 CFR Part 11, GAMP5, ICH Q9, and Data Integrity; proficient in validation documentation, risk assessments, and validation protocols (IQ/OQ/PQ). Preferred: experience with Veeva QualityDocs, ComplianceWire, CTMS, and regulatory systems; excellent communication skills. High-Value: focus on pharmaceutical/biotech environments, validated GXP systems, validation strategy development, vendor management, and compliance monitoring. Work setup: headquarters-based in the US; salary range $160,600–$189,000.