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 ResponsibilitiesLead the development and implementation of IT assurance and compliance processes for R&D IT systemsOversee testing and assurance of R&D IT systems to ensure they meet regulatory and performance standardsCollaborate with R&D teams to align IT assurance efforts with project timelines and objectivesRequired Qualifications and EducationBachelor's degree in computer science or engineering, or 10+ years of relevant experience in GxP system technology10+ years of experience implementing and validating regulated GxP Clinical and Commercial IT Systems10+ years of experience in Quality methodologies, including Risk Assessment and Change ControlPreferred experience with IT systems such as eTMF, SAS, and other GCP / GLP / CRO / RWE systemsKnowledge of GMP, GCP, GLP, FDA, and EMA regulatory requirements applicable to Biologics
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