IM Regulatory Validation Lead

Validation Lead

Experienced validation lead to support end to end validation ownership of a Unified Regulatory Platform (URP) built on Veeva and AWS based cloud stack. 8+ years' experience in computer system validation or quality management or business analysis in GxP application area. Act as single point of accountability for validation deliverables. Responsible to author validation deliverables which includes validation/compliance plan, report, RTM, data flow map, change controls, etc.

Developing validation strategy for projects. Provide general guidance and support regarding SDLC and CSV processes, ensuring best practices are followed. Providing audit support and support application lifecycle management. Prepare change control documentation and coordinate associated go-live activities to ensure seamless implementations. Ability to guide cross-functional teams. Broad experience in computer system validation (CSV) and testing. Acquainted with Good Clinical Practices (GCP) regulatory requirements and FDA 21 CFR Part 11.

Clear written and verbal communication, especially for technical documentation. Solid understanding of the fundamentals of iterative and incremental software development. Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems. Skilled in project planning, execution and minimal rework strategies. Capable of risk identification and mitigation, especially in regulated environments. Strong analytical and problem solving.