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Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.
Our lead product candidate, lysergide tartrate (our proprietary orally disintegrating tablet form of lysergide (LSD) D-tartrate), represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.
Guided by the recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.
Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!
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:
Validation Lifecycle:
Data Integrity:
Supplier and CRO Oversite:
Cross Functional Support:
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
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. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:
