Jennifer Mahon Email & Phone Number

• Over twenty years of experience specializing in the validation of regulated computerized software systems including document management, product lifecycle management, content management, enterprise resource planning, electronic common technical document (eCTD) submission and validation tools, to ensure compliance to current FDA, EMEA, and other regional-specific GxP standards, in addition to compliance with the DQSA Secure Supply Chain mandate.• Proven ability to execute and lead activities and deliverables on complex projects from concept to fully operational status following full change control procedures.• Effectively plan and resource task-based initiatives and client customized software implementations efficiently executing to plan while ensuring quality standards and commitments are met.• Promotes collaborative, cooperative and productive working relationships internally within and across departments and externally with clients, and proven to be a productive and effective member of the organization.• Competence in FDA, GxP, and 21 CFR Part 11 regulations for software and computer systems.• Possess strong analytical abilities, solid presentation and project management skills, and proficient written and verbal communication skills.

Listed skills include 21 Cfr Part 11, Validation, Computer System Validation, Gxp, and 15 others.