[Hiring] Senior CSV Analyst @Definium Therapeutics

Role Description

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 Annex 11 and Definium SOPs, 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 to present their systems.
  • Support responses and CAPAs 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 protocols, traceability matrices and validation summary reports, in line with GAMP 5.
  • Perform validation impact assessments for change requests, including vendor-driven SaaS 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.
  • 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, including review of vendor validation packages, SOC 2 reports and quality agreements.
  • Help assess sponsor oversight of CRO-hosted clinical systems in line with ICH E6(R3) Good Clinical Practice expectations.
• Cross Functional Support:
  • Coordinate with IT and Finance on SOX ITGC 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, consistent with FDA guidance.
  • Contribute to updates of CSV-related SOPs, work instructions and templates.

Qualifications

• 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 or equivalent.

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents.
• 401(k) program with company match and vesting after the turn of the first month after your start date.
• Flexible time off.
• Generous parental leave and some fun fringe perks!

Compensation

The starting base pay range for this position: $125,000 — $150,000 USD. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location. Employees in this role may be entitled to additional compensation, including bonus and equity.