IT CSV Manager

Quva

IT CSV Manager overseeing the strategy and compliance of validation for GxP-regulated IT systems in a remote setup. Contributing to a mission-driven organization focused on healthcare access and data insights.

Posted 6/18/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Computer System ValidationRisk ManagementChange ControlData IntegrityQuality PracticesSystem Validation ProjectsStandard Operating ProceduresWork InstructionsGxP ComplianceCFR Part 11

Soft Skills

CollaborationTrainingCommunicationProject PlanningOrganizational Skills

Certifications & Qualifications

Bachelor’s Degree in Information Technology

Industry Keywords

GxPCorporate Quality AssuranceInternal AuditsExternal AuditsRegulatory Compliance

About the role

Key responsibilities & impact

Develops the Computer System Validation strategy for IT systems supporting GxP business processes throughout the complete system lifecycle
Collaborates with the Corporate/Clinical Quality Assurance in the development, implementation and execution of CSV process and procedures
Develops Standard Operating Procedures and Work Instructions for the complete system lifecycle, including Risk Management, Computer System Validation, and Change Control
Partners with System/Process Owners to implement and maintain GxP computerized systems in a validated state and in accordance with regulatory agency regulations and internal requirements
Manages and oversees validation of IT GxP systems
Manages the change control process across all the IT GxP systems
Collaborates with Corporate QA for IT system vendor audit and qualification
Represents IT during internal and external agency audits and inspections
Develops IT CSV Training program and manages compliance of the training program for applicable IT team members

Requirements

What you’ll need

Bachelor’s degree in information technology, or related field, required
5 -7 years of experience in developing and implementing computer system validation, data integrity, and quality practices;
Excellent understanding of the CFR Part 11 and Annex 11 regulations for computer systems
Collaborative skills in working with a wide range of users including Corporate Quality Assurance to develop Computer System Validation program
Experience with educating and training users at different levels on the computer system validation process and practices
Experience with planning and scheduling the timely completion of system validation projects
18+ years of age
Able to successfully complete a drug and background check
Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas.

Benefits

Comp & perks

Comprehensive health and wellness benefits including medical, dental and vision
401k retirement program with company match
22 paid days off plus 8 paid holidays per year
Occasional weekend and overtime opportunities with advance notice