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 approaches.
• Experience supporting validation lifecycle activities (impact assessment, risk assessment, testing, traceability, reporting)
• Strong understanding of Quality Management Systems (QMS), including Deviation, CAPA, Change Control, Document Management, and Training processes.
• Experience supporting audits, inspections, and compliance assessments, including CAPA tracking and remediation.
• Hands-on experience with quality and enterprise systems such as Trackwise, Veeva Vault, SAP, LIMS, or similar platforms.
• Working knowledge of SAP validation and compliance requirements within regulated environments.
• Understanding of global regulatory requirements (GxP, 21 CFR Part 11, Annex 11) and their application in quality processes.
• Familiarity with data integrity principles (ALCOA+) and electronic records/e-signature compliance.
• Strong documentation skills, including SOPs, work instructions, and quality records.
• Ability to collaborate with cross-functional teams (Business, IT, Operations, Manufacturing, Labs).
• Strong analytical, problem-solving, and communication skills.
• Effective stakeholder management and client-facing skills in a consulting environment.

Good-to-Have Skills & Attributes

• Exposure to digital quality transformation initiatives, including implementation or enhancement of QMS platforms.
• Familiarity with Agile delivery models and working in cross-functional project environments.
• Awareness of AI/ML use in regulated environments and associated quality/governance considerations.
• Exposure to process optimization and operational excellence initiatives.
• Experience contributing to business development activities (proposals, presentations, client interactions).
• Ability to contribute to standardization, innovation, and practice development initiatives.

What we look for

• Professionals with strong quality mindset, regulatory rigor, and consulting acumen.
• Ability to operate in complex, fast‑paced transformation programs.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries
• Individuals who combine technical depth with stakeholder confidence

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you

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