IM Regulatory 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