Advance your career at EY by joining a global leader in consulting, specializing in Enterprise Risk and Regulatory Compliance. This Manager role focuses on Computerized System Validation (CSV) for Manufacturing Execution Systems (MES) like PAS X, crucial for pharmaceutical clients. You'll drive compliance with global regulations and strategic initiatives for operational excellence, building a successful career in a supportive, inclusive culture.

As part of the EY-ER- Regulatory Compliance team, you will understand client business needs and deliver solutions aligned with EY guidelines. You will establish and strengthen relationships, ensuring high-quality deliverables and operational efficiency. Proactively identify and escalate risks while leading internal initiatives, contributing to a better working world.

Develop comprehensive validation strategies and master plans for PAS X implementations, including CSV/CSA, risk assessments, and compliance with GxP standards. Ensure adherence to regulatory requirements such as 21 CFR Part 11 and EU Annex 11, while monitoring and adapting to changes. Lead the creation of all lifecycle documentation, including URS, specifications, risk assessments, and validation protocols/reports. Define test strategies, manage test execution, and oversee deviation management. Provide quality oversight for vendors and partners, validating data integrity and security controls. Validate MBRs, interfaces, and infrastructure, managing change and release processes effectively. Prepare teams for audits and inspections, driving continuous improvement. Collaborate cross-functionally and mentor validation engineers.

A Bachelor’s or Master’s degree in a relevant field is required, coupled with over 5 years of experience in Computerized System Validation (CSV/CSA) within GMP environments, specifically with MES and ideally Werum PAS-X. Proven experience validating integrations with ERP, LIMS, SCADA/PLC, historians, and shop floor equipment is essential, along with a strong understanding of GAMP 5, 21 CFR Part 11, and Annex 11. Consulting or client-facing experience is preferred, alongside excellent communication, documentation, and stakeholder management skills. Deep knowledge of GAMP 5, data integrity principles, and CSV/CSA documentation is a must.