The Senior Specialist Quality Assurance, CSV role is responsible for ensuring GxP systems are implemented, validated, and maintained in compliance with regulatory and quality standards. This role partners closely with IT and business teams to support system lifecycle activities, including vendor evaluations, software implementation, and system qualification and requalification.The QA CSV SME drives risk-based validation processes by establishing and refining policies, procedures, and work instructions, while ensuring Software Development Lifecycle (SDLC) and validation requirements are clearly defined and consistently met. This position reviews and approves validation documentation, provides guidance on data integrity best practices, and serves as the QA lead for system releases and change controls.Responsibilities:Partner cross-functionally with IT and the business to implement and maintain compliant computerized systemsProvide quality oversight for the lifecycle of computerized systems, ensuring compliance with GAMP 5, 21 CFR Part 11, and Data Integrity standardsServe as the QA CSV SME during vendor evaluations, software implementation and qualification and requalification of GxP systemsSupport continuous improvement of GxP Systems through SOP development, training, and change control managementPartner with IT and Business teams to ensure SDLC and validation requirements are clearly defined and metLead investigations for CSV-related deviations, system failures, and data integrity issues, including root cause analysisReview and approve Computer System Validation (CSV) documentation including Validation Plans, IQ/OQ/PQ protocols, and summary reportsAdvise on data integrity best practices and approachesPartner with IT to ensure inspection readiness is maintained for CSVServe as QA reviewer for all new system releases and change controlsPerform internal audits to ensure systems are maintained in a steady state and user management is under controlEnsure adherence to regulatory and quality standards throughout the software development lifecycleSupport systems and new product introduction by providing QA expertise, problem solving, and strategies for risk mitigationSupport validation and QA oversight of AI/ML-enabled GxP systems, including risk assessment for model changes and ongoing performance monitoringRequirements:7+ years experience working in the pharmaceutical/biotech space required5+ years' experience with CSV validation lifecycle managementBachelor's degree in a life science fieldExcellent 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 GuidanceProven experience in assisting validation efforts for SaaS/PaaS GxP systemsBroad understanding of Technology implementation (SaaS) and Data migrations approachesExperience validating or assessing AI/ML-based systems in a regulated environment, including understanding of model risk and change control considerationsDemonstrated experience idation plans, validation reports and test scriptsThe starting base pay range for this position is $101,147.00 - $122,757.00 Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.The Company provides competitive benefits to employees including:100% paid health benefits including Medical, Dental and Vision for you and your dependents401(k) program with company match and vesting after the turn of the first month after your start dateFlexible time offGenerous parental leave and some fun fringe perks!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.
3 months ago