RC-REGULATORY COMPLIANCE-CSV-SAP Validation-Senior

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EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –Senior –Quality Consultant - SAP S/4HANA Quality Assurance As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.   The opportunity We are seeking a Senior Quality Consultant with strong experience in Quality Assurance and regulatory compliance for SAP S/4HANA implementations within regulated environments. The role focuses on ensuring quality, validation, and compliance across SAP S/4HANA programs by embedding robust quality governance, supporting audit readiness, and enabling compliant digital transformation initiatives. The consultant will work closely with business, IT, validation, and quality stakeholders to support SAP S/4HANA implementations aligned with GxP regulations, data integrity principles, and global regulatory expectations.     Your key responsibilities

Support Quality Assurance and compliance activities for SAP S/4HANA implementations in regulated (GxP) environments Ensure alignment of SAP S/4HANA solutions with regulatory requirements (21 CFR Part 11, Annex 11, EU GMP, ICH, ISO) Review and support validation deliverables including impact assessments, risk assessments, validation strategies, test documentation, and traceability Support CSV / CSA activities for SAP S/4HANA, including system categorization, risk‑based validation approaches, and compliance documentation Participate in quality governance and oversight, ensuring adherence to regulatory requirements and client quality standards Support audit and inspection readiness, including preparation, evidence collation, and CAPA tracking related to SAP systems Collaborate with Business, IT, QA, and SAP functional teams to ensure compliant and efficient solution delivery Prepare, review, and approve quality and validation documentation such as SOPs, validation plans, test protocols, RTMs, and reports Identify and proactively escalate quality, compliance, and delivery risks to project and EY leadership Coach and guide project teams on SAP validation best practices, documentation standards, and regulatory expectations.

Bachelor’s or Master’s degree in Biotechnology, Engineering, or related field. 5+ years of experience in Quality Assurance, Validation, Regulated Compliance or GxP environments within pharmaceutical, life sciences or consulting organizations Hands‑on experience supporting SAP implementations, preferably SAP S/4HANA, in regulated environments Strong understanding of Quality Management Systems (QMS) and core quality processes (Deviation, CAPA, Change Control, Document Management, Training) Strong understanding of global regulatory requirements including, ICH and ISO Guidelines, 21 CFR Part 11, Annex 11, EU GMP Consulting or client‑facing experience preferred. Excellent communication, documentation, and stakeholder management skills.

Must-Have Skills & Attributes

Quality Assurance and compliance experience for SAP S/4HANA or SAP ECC implementations. Strong understanding of CSV / CSA principles and risk‑based validation