CSV Manager, Quality Systems Technology (QST)

Role Summary

We are looking for a Computer Systems Validation (CSV) Manager who thrives in managing validated systems, compliance initiatives, and system enhancements. This role is a great opportunity for someone who enjoys working at the intersection of technology, quality, and regulatory compliance, ensuring that validated systems supporting GxP activities are reliable, efficient, and compliant. This is a hybrid role typically requiring on-site presence at least 3 days per week.

Responsibilities

• Drive continuous improvement initiatives for Corcept’s Quality Management System (QMS) and support enhancements to validated GxP systems such as Veeva, Argus, SAS and ComplianceWire
• Collaborate with IT and QA teams to enforce requirements for validated systems
• Monitor and perform periodic system reviews, identify compliance gaps, and implement corrective actions
• Prepare for regulatory inspections and support audits by ensuring validated systems meet compliance requirements (GxP, 21 CFR Part 11, and EU Annex 11 requirements)
• Support Inspection Remediation activities and CAPA closure
• Evaluate the impact of system updates, patches, and configuration changes, ensuring compliance with GxP regulations and data integrity principles and implement the update
• Collaborate with cross-functional teams to optimize workflows, reporting capabilities, and system usability to meet business and compliance needs
• Coordinate vendor release activities and assist in resolving system issues with software and consulting vendors
• Develop GxP SOPs and support training efforts for personnel on those SOPs and related regulations

Qualifications

• Thorough understanding of quality systems that support internal GxP activities for pre-clinical, clinical, and commercial products
• Proficiency in the use of GxP-validated systems such as Veeva (eTMF, Quality, and RIM), SAS, and ComplianceWire
• Hands-on experience with QMS system implementations or other GXP systems
• Experience developing GxP SOPs and training personnel regarding those SOPs and the corresponding government regulations
• Customer-focused and able to prioritize with competing priorities

Education

• 8+ years’ experience in the development and maintenance of quality systems in clinical and commercial-stage pharmaceutical companies
• Deep knowledge of ICH Q10 & GAMP 5, 21 CFR Part 11 and Annex 11
• Familiarity with risk-based computer system validation (CSV/CSA) strategies