Director of IT R D Compliance

Job Summary

A company is looking for a Director of IT R&D Assurance and Compliance to manage IT GCP/GLP/CRO/RWE Assurance and Compliance.

Key Responsibilities

• Lead the development and implementation of IT assurance and compliance processes for R&D IT systems
• Oversee testing and assurance of R&D IT systems to ensure they meet regulatory and performance standards
• Collaborate with R&D teams to align IT assurance efforts with project timelines and objectives

Required Qualifications and Education

• Bachelor's degree in computer science or engineering, or 10+ years of relevant experience in GxP system technology
• 10+ years of experience implementing and validating regulated GxP Clinical and Commercial IT Systems
• 10+ years of experience in Quality methodologies, including Risk Assessment and Change Control
• Preferred experience with IT systems such as eTMF, SAS, and other GCP/GLP/CRO/RWE systems
• Knowledge of GMP, GCP, GLP, FDA, and EMA regulatory requirements applicable to Biologics