Senior Analyst- IT Quality and Compliance
Listed on 2026-09-19
-
IT/Tech
IT Business Analyst, IT Consultant, IT Project Manager, Cybersecurity
JOB DESCRIPTION OVERVIEW
CREO Senior Analysts in IT Quality and Compliance take on a proactive, hands-on role collaborating with senior staff to help clients navigate complex regulatory requirements while enabling modern, efficient IT solutions. This role requires independent execution, ownership of key work streams, and delivery of high-quality, client-ready Computerized System Validation (CSV) deliverables.
Senior Analysts are highly motivated, self-directed professionals with strong technical, analytical, and communication skills. In this role, you will execute IT compliance-focused work streams, distill complex regulatory and technical concepts into actionable insights, and support technology projects and operations across the life sciences industry.
This role will serve clients nationally and preferably be based in one of the US life science hubs (ideally the Research Triangle Park NC or Boston MA and alternatively San Diego or San Francisco CA)
POSITION RESPONSIBILITIES1. Lead and manage IT compliance and quality projects
Deliver client engagements focused on IT compliance, including but not limited to FDA, EU EMA, and other global health authority regulations, privacy regulations (GDPR, CCPA, etc.) or CAP/CLIA regulations.
Oversee the end-to-end lifecycle of IT compliance projects, from initial assessment and requirements gathering to implementation, validation, and post-implementation support. This includes Computer Systems Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA) per FDA guidance and GAMP 5.
Lead technical discussions, document key compliance decisions, and track action items.
Ensure that projects meet client expectations, are completed on time, and align with relevant regulations and industry best practices (including 21 CFR Part 11, EU Annex 11), emphasizing true risk-based approaches to validation.
Maintain personal billable utilization at the rate of 1700 hours per year.
Create high-quality, client-ready deliverables that communicate complex IT compliance requirements and solutions in a clear and compelling way.
Utilize advanced skills in Excel and PowerPoint to develop detailed compliance roadmaps, IT strategy documents, system validation plans, and risk assessments.
Design technology presentations and reports that articulate business value and demonstrate how the proposed solutions will address client compliance challenges, improve data integrity, and mitigate risks.
Develop Policies, Procedures, Forms, and Templates to drive regulatory compliance in the IT domain.
Develop formal systems validation documentation (eg Validation Plans, Requirements/Specifications, Risk Assessments, Test Plans, Trace Matrices etc.)
Lead data collection, IT analysis, and assessments related to IT compliance and Data Integrity.
Take the lead in gathering data and conducting analyses to understand and remediate client compliance challenges.
Conduct system audits, evaluate IT systems for compliance gaps, assess data integrity risks, and identify opportunities for compliance improvement and automation.
Assist customers to evaluate and/or implement technologies that automate compliance tasks, including ALM/VLM solutions or automated testing software, as well as ITSM solutions to manage change control.
Design technology solutions and architectures that meet regulatory requirements and incorporate best practices for data governance and security.
Develop sophisticated models for assessing IT compliance, cost structures, and risk mitigation.
Experience with qualification and/or validation of on-premises and cloud-based infrastructure…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).