GxP Validation Lead - AI & Life Sciences

Nityo Infotech Corporation; United States; Hybrid; USD 120,000 - 150,000; Full time

Job summary

Nityo Infotech Corporation is seeking a Validation Lead in the United States to drive GxP validation efforts for GEN AI-based solutions including LSMV Safety and Pharmacovigilance systems. The role requires managing end-to-end validation activities, mentoring both junior and senior staff, and coordinating with J&J managers across multiple projects in a hybrid environment.

Ideal candidates will have 7-10 years of experience in regulated industries, strong knowledge of FDA/global compliance, and

Qualifications

• 7-10 years of relevant experience in validation within pharmaceutical, biotechnology, or medical device industries.
• Experience in FDA or global regulated environments with GxP standards and risk-based validation.
• Ability to write and execute validation deliverables (requirements, validation plans, test protocols, test reports, SOPs/WIs).
• Ability to supervise and mentor junior and senior resources; lead teams or work independently.

Responsibilities

• Validate GxP GEN AI-based solutions and LSMV Safety and Pharmacovigilance systems.
• Manage end-to-end validation processes including inventory, assessments, remediations, and final dispositions.
• Coordinate with J&J managers across multiple dispositions with limited supervision.
• Define and implement risk-based validation activities in regulated environments.
• Prepare and review validation documentation: requirements, plans, test protocols, test summaries, validation reports, SOPs/WIs.
• Review system test scripts, traceability matrices, and design specifications.
• Communicate clearly, both verbally and in writing, with internal teams and remote partners.
• Collaborate with remote teams and manage multiple projects concurrently.

Skills

GxP validation

Team leadership

Communication

Remote collaboration

Job description

Nityo Infotech Corporation is seeking a Validation Lead in the United States to drive GxP validation efforts for GEN AI-based solutions including LSMV Safety and Pharmacovigilance systems. The role requires managing end-to-end validation activities, mentoring both junior and senior staff, and coordinating with J&J managers across multiple projects in a hybrid environment.

Ideal candidates will have 7-10 years of experience in regulated industries, strong knowledge of FDA/global compliance, and