Validation & IT Auditor II

What You'll Do: Review full computer system validation deliverables for regulated software, hardware, and laboratory instrumentation applications, including Validation Plans, User Requirements, User Acceptance Testing, Test Cases, Traceability Matrices and Validation Summary ReportsConduct internal audits related to validated systems and IT processes. Escalate any unresolved observations to QA managementConduct vendor audits of SaaS vendors to assess qualification status. Escalate any unresolved observations to QA managementPrepare and distribute audit reports, providing clear communication of audit observations of the relevant CTI leadership.Assist with review of auditee response plans for adequacy of corrective and preventive actions and follow through to effective resolution.Assist QA leadership team with review of non-conformance root causes and implementation of effective corrective actions related to IT processes, clinical systems and validation CAPAs.Assist with review, revision, and management of IT, validation and system related SOPsAssist QA leadership team with validation improvement initiativesProvide guidance as needed for risk assessments and/or ensuring procedural controls are in place to mitigate risk and maintain complianceAssist with implementing tools and procedures to facilitate documentation and tracking of quality assurance validation audit activities.Maintain significant knowledge in global regulatory validation requirements to provide regulatory compliance guidance and quality improvement consult to internal functions; proactively maintain in-depth knowledge of 21 CFR Part 11 ComplianceAssist with preparing training materials related to global validation requirementsAssume administrator responsibilities for quality assurance electronic systems. Create new accounts and assign appropriate roles/access.Recommend changes to current processes to provide more effective use of the quality assurance electronic systems and take the lead to implement such changesPrepare training materials and conducting training related to relevant QA topics for CTI staffCreate and format document templates & trackersWork closely with QA leadership to learn and enhance Quality Assurance responsibilitiesWhat You'll Bring:Bachelor’s degree in business administration or physical/life scienceDocumentation of exceptional performance in prior leadership role(s)At least 4 years in CRO, pharmaceutical, clinical or related fieldsAbout CTICTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.comWhy CTI?Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.