Manager, Computer Systems Validation (CSV)

Corcept Therapeutics seeks a Manager of Computer Systems Validation to oversee GXP-regulated IT systems, ensuring compliance and validated states throughout their lifecycle. The role involves developing validation strategies, managing documentation, guiding cross-functional teams, and serving as the interface between IT and Quality Assurance.

Responsibilities

• Assess, review, and oversee enterprise GXP computer systems validation across pharmaceutical platforms
• Develop validation strategies and author documentation including master plans, data migration plans, and qualification protocols
• Manage IT compliance risk assessments and ensure validated state of all GXP systems
• Provide validation guidance on data migration, system changes, and cross-functional implementation projects
• Manage external CSV consultants and serve as interface between IT and Quality Assurance teams

Requirements

• 8+ years in QA or validation in pharma/biotech environments
• Deep knowledge of 21 CFR Part 210, 211, 11, Annex 11, GAMP5, ICH Q9
• Expertise in electronic records, electronic signatures, and data integrity
• Proficiency authoring validation master plans, protocols, reports, and discrepancy documentation
• Experience managing change controls, risk assessments, and IQ/OQ/PQ protocols
• Demonstrated ability to coordinate vendor releases and system implementations