Develop validation project management deliverables as needed such as plans, qualification protocols, gap assessments, risk/impact assessments, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change control / change management and continuous improvement for GMP/GLP. Overview: The incumbent will oversee and coordinate new projects related to validation deliverables and qualifications to ensure existing and new system installations meet all internal and external compliance requirements such as 21 CFR Part 11, EU GMP, and GLP requirements throughout the systems development life cycle.