Join EY and contribute to building a better working world. As part of our Regulatory Compliance team, you'll assist clients by understanding their business needs and delivering innovative solutions aligned with EY methodologies. This role involves establishing and strengthening client relationships, ensuring high-quality project delivery, and proactively managing risks.

We are seeking an experienced Manager to lead validation and testing activities for Veeva modules and critical computerized systems in the pharmaceutical and life sciences sectors. The ideal candidate will ensure adherence to global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for operational excellence and business process transformation.

Lead Computerized System Assurance (CSA) and Computer System Validation (CSV) strategies for the Veeva Vault platform, employing a risk-based approach. Conduct risk assessments for platform changes to determine validation rigor and evidence requirements.

Define validation and testing evidence needs, ensuring risk-justified and audit-defensible test coverage. Review and approve validation deliverables, including plans, risk assessments, test evidence, and summary reports.

Ensure platform changes comply with regulations (21 CFR Part 11, EU Annex 11, GAMP 5) and internal policies. Provide compliance guidance on CSA principles for specific configurations and integrations. Support audits and inspections as the validation Subject Matter Expert (SME).

Partner with QA and Change Management to ensure appropriate validation justification and evidence in Change Control records. Stay updated on evolving CSA guidance and industry practices to advise on policy updates.

Possess a Bachelor's or Master's degree in Biotechnology, Engineering, or a related field. Require 8+ years of experience in Computer System Validation (CSV) within the pharmaceutical, life sciences, or consulting industries.

Demonstrated leadership in transitioning teams from traditional CSV to CSA practices is essential. In-depth knowledge of GAMP 5 (2nd edition), FDA CSA guidance, 21 CFR Part 11, and EU Annex 11 is required.

Experience defining risk-based testing/validation strategies that optimize documentation and testing while maintaining compliance. Experience validating cloud/SaaS platforms, with a strong preference for Veeva Vault, in a GxP environment.

Must have experience supporting regulatory inspections/audits as a validation SME. Strong stakeholder influencing skills are crucial to drive CSA adoption across delivery teams. Experience partnering with QA/Test Automation teams to align risk assessments with automated test coverage is needed.

Excellent project management, problem-solving, and communication skills are vital. Apply structured and analytical thinking to enhance delivery efficiency and achieve positive client outcomes.