GxP Validation / Release Readiness SME

Overview

We are looking for a senior GxP Validation / Release
Readiness specialist to provide independent advisory support across validation,
testing, deployment, cutover, go-live and hypercare activities for a major
pharmaceutical regulatory transformation.

Key Responsibilities

• Provide
  independent assessment of validation readiness.
  
• Assess
  GxP and pharmaceutical technology quality considerations.
  
• Review
  testing, validation and deployment dependencies.
  
• Identify
  validation and compliance risks.
  
• Assess
  readiness across Business, IT, System Integrators, data and technology
  workstreams.
  
• Identify
  critical gaps ahead of deployment.
  
• Support
  cutover-readiness assessments.
  
• Assess
  go-live readiness and key deployment risks.
  
• Provide
  recommendations around unresolved risks and dependencies.
  
• Support
  hypercare and stabilisation assessments.
  
• Assess
  change impacts relating to quality, validation and deployment.
  
• Produce
  clear assessment and decision-support materials for governance forums.
  
• Support
  coordination of validation, quality and readiness inputs.
  

Requirements

Essential Experience

• Strong
  experience in GxP-regulated pharmaceutical environments.
  
• Significant
  pharmaceutical validation experience.
  
• Experience
  with complex technology transformation programmes.
  
• Experience
  with testing and validation of enterprise systems.
  
• Experience
  with release readiness and deployment.
  
• Experience
  with cutover and go-live.
  
• Experience
  assessing business and technology readiness.
  
• Strong
  understanding of pharmaceutical technology quality requirements.
  
• Experience
  identifying risks, dependencies and readiness gaps.
  
• Ability
  to communicate effectively with senior Business and IT stakeholders.
  

Desirable

• Veeva
  Vault / Veeva Vault RIM experience.
  
• Regulatory
  transformation experience.
  
• Previous
  Novartis experience.
  
• Freeway
  or comparable regulatory-platform transformation.
  
• Experience
  with large-scale data migration and validation.
  

On-site Requirement

Must be available for Basel attendance during validation,
cutover and go-live phases.

Ideal Background

Senior CSV/GxP Consultant / Validation Lead / Quality
Technology SME / Release Readiness Lead / GxP Transformation Consultant.