Senior Specialist, Quality Assurance, CSV

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Definium Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

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

• Partner cross-functionally with IT and the business to implement and maintain compliant computerized systems • Provide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standards • Serve as the QA CSV SME during vendor evaluations, software implementation and qualification and requalification of GxP systems • Support continuous improvement of GxP Systems through SOP development, training, and change control management • Partner with IT and Business teams to ensure SDLC and validation requirements are clearly defined and met • Lead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysis • Review and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reports • Advise on data integrity best practices and approaches • Partner with IT to ensure inspection readiness is maintained for CSV • Serve as QA reviewer for all new system releases and change controls • Perform internal audits to ensure systems are maintained in a steady state and user management is under control • Ensure adherence to regulatory and quality standards throughout the software development lifecycle • Support systems and new product introduction by providing QA expertise, problem solving, and strategies for risk mitigation • Support validation and QA oversight of AI/ML-enabled GxP systems, including risk assessment for model changes and ongoing performance monitoring

🎯 Requirements

• 7+ years experience working in the pharmaceutical/biotech space required • 5+ years’ experience with CSV validation lifecycle management • Bachelor’s degree in a life science field • Excellent understanding of 21 CFR Part 11/Annex 11 compliance and Computer System Validation (CSV), Computer System Assurance (CSA), IT SLDC best practices, General Data Protection Regulation (GDPR) regulations, and GAMP 5 Guidance • Proven experience in assisting validation efforts for SaaS/PaaS GxP systems • Broad understanding of Technology implementation (SaaS) and Data migrations approaches • Experience validating or assessing AI/ML-based systems in a regulated environment, including understanding of model risk and change control considerations • Demonstrated experience in reviewing key validation deliverables such as user requirements, validation plans, validation reports and test scripts

🏖️ 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!