Quality Assurance Validation & IT, Director

What You'll Do: 

• Lead and manage QA staff responsible for audit execution and IT quality initiatives.
• Mentor QA team members and support development through training in best auditing practices and IT quality standards.
• Drive IT Quality strategy through continuous improvement initiatives, special projects, and process enhancements.

• Plan, conduct, and oversee IT and computerized systems audits, including internal, vendor, and for-cause to ensure compliance with GxP regulations, contractual obligations, and internal standards.
• Prepare, or review, and approve audit plans, reports, and audit responses within defined timelines.
• Support sponsor audits and regulatory authority inspections.
• Report audit and inspection outcomes and support Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPAs), and effectiveness checks through closure.

• Monitor SaaS providers compliance using risk-based approaches and performance signals.
• Partner cross-functionally (Vendor Management, IT, and Business teams) to ensure alignment on quality standards.
• Support IT related vendor qualification and provide oversight of the GxP audit program.
• Contribute audit insights and trends to Quality Risk Management for continuous risk mitigation.

• Provide Quality oversight of Computer System Life Cycle (CSLC) activities, including implementation, validation, change management, maintenance, periodic review, and decommissioning.
• Review and approve validation documentation and ensure adherence to data integrity and Electronic Records/Electronic Signatures (ERES) requirements.
• Serve as QA Subject Matter Expert (SME) for CSLC frameworks and IT quality processes.
• Ensure changes to systems and infrastructure are controlled, risk-assessed, and compliant with regulatory expectations.

• Review IT related SOPs and policies.
• Lead initiatives to strengthen data integrity, inspection readiness, and compliance processes.
• Collaborate with IT and business functions to streamline GxP system compliance processes.
• Support training programs to enhance organizational understanding of IT quality and compliance requirements.
• Review and approve investigations, deviations, RCA, CAPAs, and effectiveness checks related to audits, inspections, and quality events. Ensure timely resolution and closure of quality events.

What You'll Bring:

• Bachelor's Degree or equivalent combination of education and experience
• 5 years of experience in Software Development Life Cycle (SDLC), testing, and validation in a regulated industry and IT auditing (internal and vendors)
• At least 10 years in CRO, pharmaceutical, clinical or related fields
• Fluent in English

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 the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com