Join EY's Enterprise Risk - Regulatory Compliance team as a Senior Consultant specializing in CSV and Veeva Validation. You will play a pivotal role in ensuring clients' compliance with global regulatory standards by leading validation and testing activities for critical computerized systems. This is an excellent opportunity to shape your career in a supportive, inclusive, and globally connected environment, contributing to a better working world.

As a senior member of the team, you'll be instrumental in understanding client needs and delivering robust solutions aligned with EY methodologies. You'll build and maintain strong relationships, drive projects to successful completion with high-quality deliverables, and proactively manage risks. Your leadership will foster operational efficiency and contribute to internal EY initiatives.

Lead comprehensive validation and testing efforts for various Veeva modules and regulated computerized systems for global pharmaceutical clients.

Define the Computerized System Assurance (CSA) and CSV strategy, incorporating a risk-based validation approach for the Veeva Vault platform. Ensure compliance with global regulatory standards such as FDA, EMA, and MHRA.

Conduct thorough risk assessments for platform changes to determine appropriate validation rigor and evidence requirements. Review and approve all validation deliverables, including plans, risk assessments, test evidence, and summary reports.

Provide expert compliance guidance on CSA principles to internal teams and vendors. Support internal and external audits, acting as the primary validation Subject Matter Expert (SME) during inspections and readiness activities. Partner closely with QA and Change Management to ensure appropriate validation justification is documented in Change Control records.

A Bachelor's or Master's degree in Biotechnology, Engineering, or a related field is required. We are seeking individuals with 5+ years of experience in Computer System Validation (CSV) within the pharmaceutical, life sciences, or consulting sectors, specifically demonstrating leadership in transitioning teams from traditional CSV to CSA practices.

Deep knowledge of GAMP 5 (2nd edition), FDA CSA guidance, 21 CFR Part 11, and EU Annex 11 is essential. Proven experience in defining risk-based testing and validation strategies for cloud/SaaS platforms, ideally Veeva Vault, in a GxP environment is crucial. The ability to influence stakeholders and drive the adoption of CSA thinking across cross-functional teams is a key requirement. Experience supporting regulatory inspections as a validation SME is also necessary.