Sr. CSV Analyst

The Senior CSV Analyst will add experienced capacity to Definium’s computer system validation function during a pivotal period. Working at the direction of the Manager, CSV/Quality IT, the analyst will support the full validation lifecycle across our GxP systems and help prepare the company for regulatory inspections, including an FDA (U.S. Food and Drug Administration) PAI (Pre-Approval Inspection) connected to our NDA (New Drug Application) and future EMA (European Medicines Agency) inspections.

We are looking for someone who can be productive from the first week: a practitioner who has sat through inspections, knows what inspectors ask for, and can write validation documentation that stands up to scrutiny.

Responsibilities:

Inspection Readiness:

• Assist with gap assessments of existing validation packages against 21 CFR Part 11, EU GMP (Good Manufacturing Practice) Annex 11 and Definium SOPs (Standard Operating Procedures), and help plan and execute remediation
• Help maintain the GxP computerized system inventory, including risk classification, validation status, system ownership and supplier information
• Prepare inspection-ready system summaries and storyboards that explain each system’s intended use, validated state and controls
• Support the inspection back room: retrieve documents, track and fulfill inspector requests, and prepare system owners and SMEs (Subject Matter Experts) to present their systems
• Support responses and CAPAs (Corrective and Preventive Actions) arising from inspection observations, including FDA Form 483 observations, and internal or external audit findings

Validation Lifecycle:

• Lead and support validation activities for new and existing GxP computerized systems using a risk-based CSA approach
• Develop and review validation strategies appropriate to system intended use, complexity, GxP impact, and risk
• Author, review and execute validation deliverables, including validation plans, user and functional requirements, risk assessments, IQ/OQ/PQ (Installation, Operational and Performance Qualification) protocols, traceability matrices and validation summary reports, in line with GAMP 5 (Good Automated Manufacturing Practice), Second Edition
• Perform validation impact assessments for change requests, including vendor-driven SaaS (Software as a Service) releases for Veeva and Medidata
• Conduct and document periodic reviews of validated systems, User Access and Audit trail review
• Document and resolve test deviations and incidents during execution

Data Integrity:

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

Supplier and CRO Oversite:

• Support qualification and audits of GxP software suppliers and CROs (Contract Research Organizations), including review of vendor validation packages, SOC 2 (System and Organization Controls) reports and quality agreements
• Help assess sponsor oversight of CRO-hosted clinical systems in line with ICH (International Council for Harmonization) E6(R3) Good Clinical Practice expectations

Cross Functional Support:

• Coordinate with IT and Finance on SOX (Sarbanes-Oxley) ITGC (IT General Controls) evidence where GxP and SOX controls overlap, such as access management and change management for NetSuite and Coupa
• Contribute to the evolution of Definium’s validation approach toward CSA (Computer Software Assurance), consistent with FDA guidance
• Contribute to updates of CSV-related SOPs, work instructions and templates

Requirements:

Bachelor’s degree in life science, engineering, computer science or related field, or equivalent experience

Minimum 6 years of computer system validation experience in an FDA-regulated pharmaceutical or biotechnology environment

Direct participation in at least one FDA or EMA inspection, or in a formal inspection readiness program, including back-room support

Hands-on validation of cloud or SaaS applications, including vendor-managed release cycles

Working knowledge of 21 CFR Part 11, 21 CFR Parts 210/211, 312 and 314, EU GMP Annex 11, GAMP 5 and FDA data integrity guidance

Strong technical writing skills, with a record of producing clear, inspection-ready validation documentation

Ability to work independently and manage multiple priorities in a fully remote role with tight timelines

Occasional travel to headquarters, supplier or CRO sites, and to support on-site regulatory inspections

Preferred:

Validation experience with Veeva Vault and Medidata products

Experience supporting a PAI or a company’s transition from clinical to commercial stage

Practical exposure to CSA methodology

Familiarity with SOX ITGC requirements at a public company

Experience with electronic validation tools such as Kneat or ValGenesis

Experience in small or growing companies where the validation team is lean and hands-on

Professional certification such as ASQ CQA (American Society for Quality Certified Quality Auditor) or equivalent