EY is seeking a Senior Quality Consultant to join our Regulatory Compliance team. You will play a crucial role in ensuring quality and compliance for SAP S/4HANA implementations within regulated industries. This position offers the opportunity to build a unique career within a supportive, inclusive, and global environment, contributing to a better working world.

Your responsibilities will include supporting Quality Assurance and compliance for SAP S/4HANA in GxP environments, ensuring alignment with global regulatory requirements like 21 CFR Part 11 and EU GMP. You will review validation deliverables, support CSV/CSA activities, and participate in quality governance. Additionally, you'll assist with audit readiness, collaborate with cross-functional teams, and prepare quality documentation.

Further duties involve identifying and escalating risks, and coaching project teams on SAP validation best practices. You will also be involved in preparing, reviewing, and approving quality and validation documentation such as SOPs, validation plans, and test protocols, ensuring adherence to client quality standards and regulatory expectations.

We require a Bachelor’s or Master’s degree in Biotechnology, Engineering, or a related field, coupled with over 5 years of experience in Quality Assurance, Validation, or Regulated Compliance within pharmaceutical, life sciences, or consulting settings.

Key qualifications include hands-on experience with SAP S/4HANA implementations in regulated environments, a strong grasp of Quality Management Systems, and in-depth knowledge of global regulatory requirements. Consulting or client-facing experience is preferred, alongside excellent communication, documentation, and stakeholder management skills. Must-have skills also encompass CSV/CSA principles, validation lifecycle activities, and experience with quality enterprise systems like TrackWise or Veeva Vault.