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 Reports


* Conduct internal audits related to validated systems and IT processes.

Escalate any unresolved observations to QA management


* Conduct vendor audits of SaaS vendors to assess qualification status.

Escalate any unresolved observations to QA management


* Prepare 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 SOPs


* Assist QA leadership team with validation improvement initiatives


* Provide guidance as needed for risk assessments and/or ensuring procedural controls are in place to mitigate risk and maintain compliance


* Assist 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 Compliance


* Assist with preparing training materials related to global validation requirements


* Assume 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 changes


* Prepare training materials and conducting training related to relevant QA topics for CTI staff


* Create and format document templates & trackers


* Work closely with QA leadership to learn and enhance Quality Assurance responsibilities

What You'll Bring:



* Bachelor's degree in business administration or physical/life science


* Documentation of exceptional performance in prior leadership role(s)


* At least 4 years in CRO, pharmaceutical, clinical or related fields

About CTI

CTI 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 ...