IT Quality- Consultant

Job Description

Position Summary This role offers a compelling opportunity to work with leading clients in the life sciences and healthcare space, supporting regulatory compliance, governance, and quality system validation initiatives. Youll be part of a dynamic team, driving innovation and ensuring adherence to global standards in regulated environments. Key Responsibilities Regulatory Compliance: Identify and manage regulatory risks to support clients in compliance, governance, and control frameworks. Project Leadership: Lead and coordinate cross-functional teams for new product development, system validations, and quality assurance activities. Process Improvement: Assist clients in developing strategies for process improvements that align with the needs of the quality organization. Validation Expertise: Author validation strategies, protocols, and summary reports. Lead end-to-end computerized system validation (CSV) activities (experience is mandatory ). Plan, manage, and execute IQ, OQ, and PQ activities in accordance with cGMP. Cross-Functional Coordination: Collaborate with R&D, Engineering, Software Development, IT, Manufacturing, and QA teams for successful project execution and training. Documentation & Review: Review and approve validation lifecycle documentation. Identify and resolve validation deviations with appropriate CAPAs. Provide quality review of change requests related to processes, IT infrastructure, equipment, and systems. Project Governance: Manage project updates, escalation closures, and strategic decisions with senior management. Training & Knowledge Transfer: Initiate workshops and training sessions to build competence across teams. About the Team Deloittes Regulatory & Operational Risk Life Sciences & Healthcare (R&OR LSHC) team provides specialized validation services addressing regulatory requirements (GxP, Part 11) and governance controls across people, processes, and technology. Our mission is to help organizations evolve through disruption with strategic resilience and compliance excellence. Required Qualifications & Experience Bachelors degree (or equivalent) 2.5–5 years of experience in the pharmaceutical or medical device industry Strong understanding of quality systems and regulatory compliance Hands-on experience with: Computer system validation (CSV) Software development lifecycle methodologies (GAMP5, Agile, Waterfall) Demonstrated project management skills on medium to large-scale projects Proficiency in identifying risks, analyzing problems, and implementing effective solutions Strong communication and presentation abilities Team-oriented mindset with a collaborative approach Preferred Qualifications Master’s degree in a relevant discipline In-depth knowledge of pharma and medical device quality systems Understanding of design controls , manufacturing processes , and risk management principles