Senior CSV Analyst

Definium Therapeutics is a late-stage clinical biopharmaceutical company focused on developing psychedelic-based treatments for psychiatric and neurological disorders, such as generalized anxiety, major depressive disorder, PTSD, and autism spectrum disorder (ASD). Their lead product candidate is lysergide tartrate (a proprietary LSD tablet), and they are also developing DT402, an MDMA derivative for ASD.

The Senior CSV Analyst will support the full validation lifecycle for GxP systems, ensuring readiness for regulatory inspections, including an upcoming FDA Pre-Approval Inspection (PAI) tied to their NDA (New Drug Application) and future EMA inspections. This role requires immediate productivity, with experience in inspections, validation documentation, and regulatory compliance.

Responsibilities:

Inspection Readiness:

• Conduct gap assessments of validation packages against 21 CFR Part 11, EU GMP Annex 11, and Definium SOPs, planning remediation efforts
• Maintain the GxP computerized system inventory, including risk classification, validation status, ownership, and supplier details
• Prepare inspection-ready system summaries and storyboards detailing system use, validation status, and controls
• Support inspection backroom operations: document retrieval, inspector request tracking, and SME preparation
• Address FDA Form 483 observations and CAPAs (Corrective and Preventive Actions) from inspections or audits

Validation Lifecycle:

• Lead validation activities for new/existing GxP systems using a risk-based CSA (Computer Software Assurance) approach
• Develop and review validation strategies based on system complexity, GxP impact, and risk
• Author, review, and execute validation deliverables, including IQ/OQ/PQ protocols, traceability matrices, and validation reports following GAMP 5
• Assess validation impacts for change requests, including SaaS releases for Veeva and Medidata
• Conduct periodic reviews of validated systems, user access, and audit trails
• Document and resolve test deviations and incidents during execution

Data Integrity:

• Assist with data integrity assessments against ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available)
• Develop and perform audit trail review procedures, verifying record retention and archival controls
• Support decommissioning of ZenQMS during migration to Veeva Vault QMS, including data migration verification and system retirement documentation

Supplier and CRO Oversight:

• Qualify and audit GxP software suppliers and CROs, reviewing vendor validation packages and SOC 2 reports
• Assess sponsor oversight of CRO-hosted clinical systems per ICH E6(R3) Good Clinical Practice

Cross-Functional Support:

• Coordinate with IT and Finance on SOX ITGC evidence for overlapping GxP and SOX controls (e.g., access/change management for NetSuite and Coupa)
• Contribute to evolving Definium’s validation approach toward CSA, aligned with FDA guidance
• Update CSV-related SOPs, work instructions, and templates