Senior CSV Analyst

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $125k - $150k / year

⏰ Full Time

🟠 Senior

🧐 Analyst

👻 Ghost score 4%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Definium Therapeutics is a clinical-stage biotechnology company developing precision psychedelic-derived therapeutics for psychiatric and neurodevelopmental disorders. The company focuses on pharmaceutically optimized formulations of lysergide (LSD) and an R-enantiomer of MDMA to treat conditions such as major depressive disorder, generalized anxiety disorder, and core symptoms of autism spectrum disorder, advancing candidates through preclinical and clinical trials with a science-led, evidence-backed approach.

📋 Description

• 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 • Support the inspection back room by retrieving documents, tracking and fulfilling inspector requests, and preparing system owners and SMEs to present their systems • Support responses and CAPAs arising from inspection observations and audit findings • Lead and support validation activities for new and existing GxP computerized systems using a risk-based CSA approach • Develop and review validation strategies • 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 • 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 trails • Document and resolve test deviations and incidents • Assist with data integrity assessments against ALCOA+ principles • Develop and perform audit trail review procedures and verify record retention and archival controls • Support decommissioning of ZenQMS following migration to Veeva Vault QMS • 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) expectations • Coordinate with IT and Finance on SOX ITGC evidence for NetSuite and Coupa • Contribute to the evolution of the validation approach toward CSA • 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 • Validation experience with Veeva Vault and Medidata products preferred • Experience supporting a PAI or a company’s transition from clinical to commercial stage preferred • Practical exposure to CSA methodology preferred • Familiarity with SOX ITGC requirements at a public company preferred • Experience with electronic validation tools such as Kneat or ValGenesis preferred • Experience in small or growing companies where the validation team is lean and hands-on preferred • Professional certification such as ASQ CQA or equivalent preferred

🏖️ 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 • Some fun fringe perks • Additional compensation, including bonus and equity may be available