Embark on a career journey as a Senior Consultant in Business Consulting Risk, specializing in the TMT sector and Digital Risk. EY is a global leader dedicated to building a better working world through assurance, tax, transaction, and advisory services. We foster a culture of continuous learning, offering unparalleled training, growth opportunities, and creative freedom. Your career is yours to build here, with limitless potential and fulfilling experiences.

The TMT industry is experiencing rapid convergence, presenting both exciting opportunities and complex challenges. We empower TMT organizations to enhance employee and customer experiences, achieve operational excellence, and protect their data and reputation. Our focus is on enabling strategic M&A, mitigating risks, and transforming companies into leaders of the future.

Within EY Consulting, we drive business transformation through people, technology, and innovation. Our client-centric approach delivers long-term value by addressing their most strategic challenges. We are organized into Business Consulting, Technology Consulting, and People Advisory Services. We assist clients in navigating the interplay between risk and opportunity, ensuring they can achieve their future business strategies.

Key responsibilities include conducting assessments of computer systems and processes for Life Sciences clients to ensure compliance with procedures, best practices, and regulatory requirements. You will create and review crucial Computer System Validation (CSV) deliverables such as user requirements, system specifications, validation plans, and qualification plans. Provide expert guidance and oversight for validation activities on projects involving GxP-relevant computer systems, collaborating closely with project team members to integrate quality and compliance throughout the system lifecycle. Responsibilities also extend to reviewing and approving CSV work products, ensuring the thoroughness of validation planning and timely completion of deliverables.

To excel in this role, you should possess hands-on experience in Quality and Compliance, with a strong background in computer system validation for Enterprise Applications (LIMS, ERPs, LMS, RPA, CTMS, etc.). Experience within an FDA-regulated environment, coupled with a solid understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and risk-based validation principles, is essential. Familiarity with validation and testing tools like HP ALM and Azure DevOps (ADO) is considered a significant advantage, as is prior experience in training validation resources.

Essential qualifications include a graduate degree from a reputable university and 3 to 13 years of overall CSV experience. You must have practical, hands-on experience with 21 CFR and CSV principles. We seek individuals who thrive in collaborative environments, providing services across diverse client departments while adhering to commercial and legal mandates. A practical, problem-solving approach, delivering insightful and actionable solutions, is crucial. We value agility, curiosity, mindfulness, sustained positive energy, adaptability, and creativity in our team members.