Director of IT R D Compliance
Company: VirtualVocations
Location: Flushing
Posted on: October 16, 2024
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Job Description:
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
Keywords: VirtualVocations, Westport , Director of IT R D Compliance, Executive , Flushing, Connecticut
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