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
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