Senior Technical Lead

Job Summary

Managing end-to-end validation processes in a regulated environment, the full-time Senior Technical Lead will oversee GxP GEN AI solutions and LSMV Safety and Pharmacovigilance systems while providing guidance and support to junior and senior resources.

Key Responsibilities

• Validate GxP GEN AI based solutions and manage multiple dispositions for various stakeholders with limited supervision
• Lead and advise teams through inventory assessments, remediations, and final dispositions in the pharmaceutical, biotechnology, or medical device industry
• 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, specifically within the pharmaceutical, biotechnology, or medical device industry
• Strong understanding of GxP standards and risk-based validation methodologies
• Experience in writing and reviewing validation documentation and test scripts
• Ability to work independently and lead teams effectively
• Familiarity with QA methodologies and compliance requirements