Senior Specialist, Quality Assurance, CSV

Definium Therapeutics

Senior Specialist in Quality Assurance ensuring compliance for GxP systems at Definium Therapeutics. Collaborating with IT and business teams to implement and maintain validation processes.

Posted 7/15/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $101,147 - $122,757 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in Computer System Validation (CSV) and compliance with regulatory standards such as 21 CFR Part 11 and GAMP 5, with a strong focus on quality oversight and risk management in GxP environments. Proven ability to lead validation efforts for AI/ML-enabled systems and ensure adherence to software development lifecycle best practices.

Highest-signal resume keywords

Computer System Validation (CSV)GxP Compliance21 CFR Part 11SaaS/PaaS ValidationAI/ML System Assessment

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Computer System Validation (CSV)Validation PlansIQ/OQ/PQ ProtocolsRoot Cause AnalysisData Integrity StandardsSOP DevelopmentChange Control ManagementRisk AssessmentValidation Lifecycle ManagementTechnology Implementation

Soft Skills

Problem SolvingCollaborationQuality OversightCommunication

Tools & Technologies

GxP SystemsSaaSPaaSAI/ML Systems

Industry Keywords

PharmaceuticalBiotechData MigrationGeneral Data Protection Regulation (GDPR)Software Development Lifecycle (SDLC)

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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!