Join our Enterprise Technology & Performance team as a Senior Consultant, driving functional excellence and innovation in the life sciences and healthcare sectors. This role is crucial for ensuring enterprise technology acts as a powerful enabler for long-term growth.

We are seeking a seasoned professional with extensive experience in quality assurance and computerized system validation (CSV) within regulated environments. Your expertise will be vital in supporting business requirements, technical designs, and test strategies, ensuring agility and speed in project delivery.

As a Senior Consultant, you will act as a Validation Subject Matter Expert, contributing to the development of critical project documentation. You will be responsible for establishing robust validation strategies that promote agility and efficient delivery. Your role involves setting up validation processes and ensuring compliance with regulatory standards for IT projects and system upgrades.

You will manage end-to-end validation activities, build strong collaborative relationships with domain and enterprise resources, and create/review essential validation deliverables. This includes GxP Assessments, Validation Plans, URS, FRS, DS, IQ, OQ, PQ, and Validation Summary Reports. Experience in data migration, cloud validation, supplier assessments, and infrastructure qualification for GxP systems is highly valued.

A minimum of 7 years of experience as a Computer System Validation Professional is required, with hands-on experience in enterprise-level applications such as ERP, MRP, QMS, and LIMS. Proficiency in regulatory requirements like GMP, 21 CFR Part 11, 21 CFR Part 820, and EU Annex 11 is essential.

Key responsibilities include performing periodic IT system reviews, managing deviations with RCA and CAPA, handling change requests, and conducting risk assessments for IT and data privacy. You will also support supplier assessments, define test strategies, and ensure comprehensive testing across all SDL phases. Excellent communication, collaboration, and problem-solving skills are necessary, along with the ability to work effectively under pressure and manage ambiguity.