GxP Validation / Release Readiness SME
Core
Senior specialist providing independent advisory support for validation, testing, deployment, cutover, go-live, and hypercare activities during pharmaceutical regulatory transformations.
Role type
Senior GxP Validation and Release Readiness SME
Builds
Regulatory transformation programs for major pharmaceutical companies
Domain
Pharmaceutical industry + GxP compliance and quality technology
Deliverable
client delivery
Required skills
GxP-regulated environment expertise, pharmaceutical validation, complex technology transformation, enterprise system testing, release readiness, cutover and go-live management, business and technology readiness assessment, risk and dependency identification
Preferred skills
Veeva Vault/RIM experience, regulatory transformation, Novartis experience, Freeway platform transformation, large-scale data migration and validation
Responsibilities
Assess validation readiness and GxP/quality considerations, review testing and deployment dependencies, identify compliance risks and readiness gaps, support cutover and go-live assessments, produce decision-support materials for governance forums, coordinate validation and quality inputs
Seniority
Senior, hands-on IC with advisory focus