CSV Manager, Quality Systems Technology (QST)

Role Summary

CSV Manager, Quality Systems Technology (QST) at Corcept. Manage validated systems, compliance initiatives, and system enhancements to ensure GxP systems are reliable, efficient, and compliant. Hybrid role with on-site presence typically at least 3 days per week.

Responsibilities

• Drive continuous improvement initiatives for Corcept‚Äôs 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

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

Education

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

Additional Requirements

• Applicants must be currently authorized to work in the United States on a full-time basis