Join our dynamic Business Consulting Risk team as a Senior Consultant, specializing in Digital Risk within the Technology, Media, and Telecommunications (TMT) sector. We empower TMT organizations to navigate industry convergence, drive innovation, and achieve agile growth strategies. Our focus is on enhancing customer and employee experiences, ensuring operational excellence, and safeguarding data, brand, and reputation.

This role is crucial in helping clients manage the intricate balance between opportunities and risks. We leverage technology and innovative approaches to solve complex strategic problems, fostering long-term value and building a better working world. You'll be part of a team dedicated to transforming businesses through people, technology, and innovation, specifically within the CNS - RISK - DIGITAL RISK domain.

Your primary responsibilities will include conducting Computer System Validation (CSV) assessments for Life Sciences clients, ensuring compliance with internal procedures, industry best practices, and regulatory requirements. You will be involved in creating and reviewing critical CSV deliverables such as user requirements, system specifications, Validation Plans, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability Matrix, Design Specs, and validation summary reports.

Additionally, you will provide guidance and oversight for validation activities on projects involving GxP-relevant computer systems. Collaborating closely with project teams, you will integrate quality and compliance elements into the system lifecycle. A key part of your role will involve reviewing and approving computer system validation work products, ensuring thorough validation planning and timely delivery of all documentation.

To excel in this role, you should possess 2 to 13 years of experience in Quality and Compliance, with hands-on computer system validation expertise on Enterprise Applications like LIMS, ERPs, LMS, RPA, and CTMS. A strong understanding of the FDA regulated environment and cGxP standards (cGMP, cGDP, cGAMP, cGLP) is essential, alongside experience with risk-based validation methodologies.

While not mandatory, experience with validation/testing tools such as HPALM or Azure DevOps (ADO) would be advantageous. The ability to work collaboratively across multiple client departments, adhering to commercial and legal requirements, is vital. We seek individuals with a practical, agile, and insightful approach to problem-solving, capable of delivering creative and effective solutions.