Join our dynamic team as a Senior Consultant focused on Digital Risk within the Technology, Media, and Telecommunications (TMT) sector. We empower TMT organizations to navigate industry convergence, drive transformation, and achieve agile growth strategies. Our focus areas include enhancing customer and employee experiences, operational excellence, data protection, and strategic M&A.

As part of EY Consulting, you will contribute to building a better working world by transforming businesses through people, technology, and innovation. Our client-centric approach addresses strategic challenges and drives long-term value. You will be instrumental in helping clients identify and manage risks, ensuring their ability to meet future business objectives.

You will conduct comprehensive assessments of computer systems and processes for Life Sciences clients, ensuring compliance with internal procedures, best practices, and regulatory requirements. Key responsibilities include creating and reviewing Computer System Validation (CSV) deliverables such as user requirements, system specifications, validation plans, qualification protocols (IQ/OQ/PQ), SOPs, traceability matrices, and validation summary reports.

Provide expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems. Collaborate closely with project team members to integrate quality and compliance elements throughout the system lifecycle. Additionally, you will review and approve computer system validation work products, ensuring thorough planning and timely completion of deliverables.

We are seeking candidates with 2 to 13 years of experience in Quality and Compliance, specifically with hands-on computer system validation (CSV) experience on enterprise applications like LIMS, ERPs, LMS, RPA, and CTMS. A strong understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation within an FDA-regulated environment is essential.

A Bachelor of Technology in Computer Science or Pharmacy is required. Experience with validation/testing tools such as HPALM or Azure DevOps (ADO) is considered an advantage, as is experience in training validation resources. The ability to work collaboratively, solve complex problems with practical solutions, and demonstrate agility, curiosity, and adaptability is crucial for success in this role.