Validation – IT Auditor II

This is a fully remote position, open to applicants in Kentucky.

📋 Description

• Evaluate comprehensive computer system validation outputs for regulated software, hardware, and laboratory instrumentation applications.

• Perform internal audits concerning validated systems and IT processes.

• Report any unresolved observations to QA management.

• Carry out vendor audits for SaaS providers.

• Create and disseminate audit reports while assisting in the review of auditee response plans.

• Support the QA leadership team in analyzing non-conformance root causes and implementing effective corrective measures.

• Maintain extensive knowledge of global regulatory validation standards.

• Develop training materials pertaining to global validation requirements.

⛳️ Requirements

• Bachelor's degree in business administration or in physical/life sciences.

• Proven track record of exceptional performance in previous leadership positions.

• Minimum of 4 years of experience in CRO, pharmaceutical, clinical, or related sectors.

🏝️ Benefits

• Comprehensive health benefits.

• Vacation packages.

• Flexible hybrid work-from-home options.

• Paid parental leave.

• Ongoing education and training through tuition reimbursement.