Senior Technical Lead

Job Summary

Managing GxP GEN AI validation solutions in the clinical space, the full-time Senior Technical Lead will oversee multiple projects with limited supervision, ensuring compliance and risk-based validation in a regulated environment.

Key Responsibilities

• Validate GxP GEN AI based solutions and manage end-to-end processes from inventory to final dispositions
• Lead and advise junior and senior resources while managing multiple dispositions for various stakeholders
• Write and execute documentation for validation deliverables, including compliance plans, test protocols, and reports

Required Qualifications

• 7-10 years of experience in the pharmaceutical, biotechnology, or medical device industry
• Strong understanding of GxP standards and risk-based validation in FDA-regulated environments
• Experience in writing and reviewing validation documentation and test scripts
• Ability to work independently and lead teams effectively in a remote setting
• Proven track record of managing multiple projects simultaneously