The Associate Director, Safety Systems Lead will be responsible for all technical aspects of the safety database environment, supporting business requirements for case processing and submission compliance, facilitating and managing interfaces with other systems, providing data to all relevant parties, serving as the safety systems technical subject matter expert and overseeing relevant safety systems vendors. Ensure safety systems remain continuously compliant, validated, and inspection-ready by overseeing computer system validation (CSV) deliverables (e.g., Validation Plans, Summary Reports, UAT), partnering with QA on audit trails/evidence, and maintaining adherence to SOPs, GxP, ICH, FDA regulations, EU Annex 11, and 21 CFR Part 11.