Senior CSV Analyst

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in evaluating existing validation packages to identify gaps against 21 CFR Part 11, EU GMP Annex 11, and Definium SOPs, and aid in planning and executing remediation.

• Help maintain the inventory of GxP computerized systems, which includes risk classification, validation status, system ownership, and supplier information.

• Prepare system summaries and storyboards that are ready for inspection.

• Support the inspection back room by obtaining documents, tracking and fulfilling inspector requests, and preparing system owners and SMEs for system presentations.

• Aid in addressing responses and CAPAs stemming from inspection observations and audit findings.

• Lead and assist in validation efforts for both new and existing GxP computerized systems utilizing a risk-based CSA approach.

• Develop and review validation strategies.

• Author, review, and execute various validation deliverables, including validation plans, user and functional requirements, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.

• Conduct validation impact assessments for change requests, including vendor-driven SaaS releases for Veeva and Medidata.

• Carry out and document periodic reviews of validated systems, user access, and audit trails.

• Document and address test deviations and incidents.

• Assist with data integrity evaluations based on ALCOA+ principles.

• Develop and implement audit trail review procedures and verify record retention and archival controls.

• Support the decommissioning of ZenQMS following the migration to Veeva Vault QMS.

• Assist with the qualification and auditing of GxP software suppliers and CROs, including reviewing vendor validation packages, SOC 2 reports, and quality agreements.

• Help evaluate sponsor oversight of CRO-hosted clinical systems in accordance with ICH E6(R3) expectations.

• Collaborate with IT and Finance to provide SOX ITGC evidence for NetSuite and Coupa.

• Contribute to the advancement of the validation approach towards CSA.

• Participate in updates of CSV-related SOPs, work instructions, and templates.

⛳️ Requirements

• Bachelor’s degree in life sciences, engineering, computer science, or a related field, or equivalent practical experience.

• A minimum of 6 years of experience in computer system validation within an FDA-regulated pharmaceutical or biotechnology setting.

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

• Hands-on experience validating 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 abilities, demonstrated by a history of producing clear, inspection-ready validation documentation.

• Capability to work independently and manage multiple priorities in a fully remote role with tight deadlines.

• 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 assisting with a PAI or a company's transition from clinical to commercial stage is preferred.

• Practical exposure to CSA methodology is preferred.

• Familiarity with SOX ITGC requirements at a public company is preferred.

• Experience with electronic validation tools such as Kneat or ValGenesis is preferred.

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

• Professional certification such as ASQ CQA or an equivalent is preferred.

🏝️ Benefits

• 100% paid health benefits including Medical, Dental, and Vision for you and your dependents.

• 401(k) program with company match and vesting beginning after the first month following your start date.

• Flexible time off.

• Generous parental leave.

• Additional fun fringe benefits.

• Additional compensation, including bonuses and equity, may be available.