Senior Technical Lead

Job Summary

Experienced professionals will find a full-time Senior Technical Lead opportunity focused on validating GxP GEN AI based solutions and managing multiple project dispositions within the pharmaceutical, biotechnology, or medical device industries.

Key Responsibilities

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

Required Qualifications

• 7-10 years of relevant experience in a regulated environment, preferably in pharmaceuticals, biotechnology, or medical devices
• Strong understanding of GxP standards and risk-based validation activities
• Experience in writing and reviewing validation documentation and test scripts
• Ability to work collaboratively with remote teams and manage multiple projects simultaneously
• Proven leadership skills with the ability to guide and mentor team members