Join EY and contribute to building a better working world. As a Staff Quality Consultant within our Regulatory Compliance team, you will play a crucial role in ensuring the quality and compliance of SAP S/4HANA implementations in regulated industries. This position offers the opportunity to develop your career within a global, inclusive culture, leveraging technology and support to become your best.

We are seeking an experienced professional with a strong background in Quality Assurance and regulatory compliance for SAP S/4HANA projects. Your focus will be on maintaining robust quality governance, supporting audit readiness, and enabling compliant digital transformations. You will collaborate closely with various stakeholders to ensure SAP S/4HANA solutions align with GxP regulations, data integrity principles, and global regulatory expectations.

Your responsibilities will include:

- Supporting Quality Assurance and compliance for SAP S/4HANA implementations in regulated (GxP) environments. - Ensuring SAP S/4HANA solutions meet regulatory requirements like 21 CFR Part 11, Annex 11, EU GMP, ICH, and ISO. - Reviewing validation deliverables, including impact assessments, risk assessments, test documentation, and traceability. - Participating in CSV/CSA activities, system categorization, and risk-based validation approaches. - Engaging in quality governance and oversight to ensure adherence to standards. - Assisting with audit and inspection readiness, including CAPA tracking. - Collaborating with business, IT, QA, and SAP teams for compliant solution delivery. - Preparing and approving quality and validation documentation (SOPs, plans, protocols, reports). - Identifying and escalating quality and compliance risks to leadership. - Coaching project teams on SAP validation best practices and regulatory expectations.

To be successful in this role, you will need:

- A Bachelor's or Master's degree in Biotechnology, Engineering, or a related field. - A minimum of 2 years of experience in Quality Assurance, Validation, or Regulatory Compliance within pharmaceutical, life sciences, or consulting settings. - Hands-on experience supporting SAP implementations, ideally SAP S/4HANA, in regulated environments. - A strong understanding of Quality Management Systems (QMS) and core quality processes (Deviation, CAPA, Change Control, Document Management, Training). - In-depth knowledge of global regulatory requirements (ICH, ISO, 21 CFR Part 11, Annex 11, EU GMP). - Consulting or client-facing experience is preferred. - Excellent communication, documentation, and stakeholder management skills.