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Skills

test planning
GxP
system testing
Communication Skills
project planning
Quality Management
Team management
User Stories
Generative AI
biotechnology
Systems Development Life Cycle
Acceptance Testing
Medical Materials
Risk-Based Testing
Traceability Matrix
Validation Protocols

Summary

Validation Lead(Computer System Validation GenAI, Agentic QMS)

Raritan, NJ (Onsite - Hybrid)

Long Term Contract

Job Details:

Experience in the Pharmaceutical, biotechnology, or medical device industry
Experience with Validation of GEN AI solutions in GxP environment is key
2+ years' experience with System Development Lifecyle
3+ years' experience in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Knowledge of FDA guidance's and industry standards (i.e., GAMP)
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
Experience in QA Methodologies, designing, reviewing and approving User Stories, Test Plans and Reports, System and UAT test scripts, Test procedures, Traceability Matrix, and Design Specs.
Strong verbal and written communication skills.
Ability to lead a team. Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance, timely reviews, and escalations to TQ management.
Ability to work with global project teams during the initial project planning phases
Ability to provide guidance on validation strategy and be able to handle the highly fluid state of the project

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10421780
Position Id: 2026-63733
Posted 6 hours ago

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Validation Lead(Computer System Validation GenAI, Agentic QMS)

Skills

Summary

Dice Job Match Score™

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Validation Lead(Computer System Validation GenAI, Agentic QMS)

Job Details

Skills

Summary

Dice Job Match Score™

Similar Jobs