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Corcept Therapeutics · 6 hours ago

CSV Manager, Quality Systems Technology (QST)

Redwood City, CA

Full-time

Hybrid

Senior Level, Lead/Staff

$154K/yr - $181K/yr

8+ years exp

Corcept Therapeutics is a leader in the research and development of cortisol modulators. They are seeking a Computer Systems Validation (CSV) Manager to manage validated systems, compliance initiatives, and system enhancements, ensuring that systems supporting GxP activities are reliable and compliant.

BiotechnologyMedicalPharmaceutical

Comp. & Benefits

No H1B

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

Qualification

GxP systemsQuality Management SystemComputer System ValidationVeevaSASComplianceWireGxP SOPsRegulatory complianceContinuous improvementCustomer-focusedTeam collaboration

Required

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

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

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