Join EY's Global Delivery Services (GDS) Consulting team as a Senior Consultant specializing in Regulatory Compliance and Computerized System Validation (CSV) with a focus on Veeva. You will play a pivotal role in helping global pharmaceutical clients navigate complex regulatory landscapes by understanding their business needs and delivering robust solutions. This role involves establishing and strengthening key relationships while ensuring high-quality deliverables and operational efficiency.

As a Senior Consultant, you will lead validation and testing activities for various Veeva modules and critical systems. Your expertise will be crucial in ensuring compliance with global regulatory standards such as FDA, EMA, and MHRA, while driving strategic initiatives for business process transformation and operational excellence.

Define and implement risk-based validation and CSA strategies for the Veeva Vault platform, ensuring alignment with modern CSA principles and CSV rigor where necessary.

Conduct risk assessments for platform changes to determine appropriate validation rigor and evidence requirements.

Collaborate with QA Engineers to define validation and testing evidence requirements, ensuring risk-justified test coverage.

Review and approve critical validation deliverables, including plans, risk assessments, test evidence, and summary reports.

Ensure all platform changes adhere to applicable regulations (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5) and internal policies.

Provide expert compliance guidance to internal teams and vendors on CSA principles.

Act as the primary validation SME during internal and external audits and health authority inspections.

Partner with Change Management to ensure appropriate validation justification and evidence are included in Change Control records.

Possess a Bachelor's or Master's degree in Biotechnology, Engineering, or a related field.

Demonstrate at least 5 years of experience in Computer System Validation (CSV) within the pharmaceutical, life sciences, or consulting sectors.

Exhibit strong influencing skills to drive practice change from traditional CSV to CSA methodologies.

Possess deep knowledge of GAMP 5 (2nd edition), FDA CSA guidance, 21 CFR Part 11, and EU Annex 11.

Have experience defining risk-based testing and validation strategies that balance efficiency with compliance.

Familiarity with validating cloud/SaaS platforms, with Veeva Vault experience being a significant advantage.

Experience supporting regulatory inspections and audits as a validation SME is essential.

Ability to work effectively with distributed teams across different time zones.