Jose Rivera

Senior Manager of Quality Audit, YPrime 07/2024 – 02/2025

• Led a team conducting over 20 audits across client, vendor, and internal operations,

enhancing audit processes and reporting mechanisms.

• Successfully facilitated and hosted over 10 client audits, contributing to new or renewed

eCOA and IRT solutions contracts.

• Developed and implemented audit compliance dashboards, improving visibility for

internal stakeholders and proactively mitigating compliance risks.

Associate Director, IT GxP Program, Rocket Pharma 04/2022 - 11/2023

• Designed and led the IT GxP program, ensuring all GxP applications met evolving

regulatory requirements and compliance standards.

• Managed NetSuite lifecycle, overseeing vendor partnerships and system enhancements

while maintaining compliance with GxP and SOX regulations.

• Led the development of User Acceptance Testing (UAT) protocols to improve system

validation and enhance user satisfaction.

Sr. Manager, Information Technology- Quality, Eisai, US 01/2021 – 04/2022

• Conducted IT audits on SaaS platforms like Veeva (QMS, eTMF, QualityDocs) and

Oracle, ensuring vendor compliance with Eisai's stringent quality standards.

• Developed and enforced validation strategies for critical systems, leading to full

regulatory compliance.

• Created an internal auditor certification program, enhancing audit capabilities and

regulatory readiness.

Business Process Architect- Information Technology, Eli Lilly 01/2016 – 11/2020

• Managed the lifecycle of global GxP applications, optimizing the development of Annual

Product Reviews (APRs) and risk assessments.

• Led a global IT services team, implementing strategic initiatives that improved

performance and compliance across multiple time zones.

• Ensured system validation and security compliance for critical GxP applications.Associate Director- Information Technology Compliance, Eli Lilly 08/2012 – 12/2015

• Hosted internal IT and privacy audits, ensuring alignment with global regulatory

frameworks.

• Developed and executed compliance strategies in adherence to FDA GxP, EMEA, and

SOX standards.

• Led a team managing audit readiness and continuous process improvements.

Sr. Business Technology Consultant – IT, Eli Lilly 10/2010 – 08/2012

• Oversaw IT qualification and validation protocols for regulated infrastructure and

applications.

• Spearheaded the development of IT global processes and compliance standards at the

site level, enhancing organizational efficiency.

• Doctor of Philosophy - PhD, Management Information Systems Nova Southeastern University-2015
• Master of Science - MS, Management Information Systems Kean University-2002
• Bachelor of Science – BS, Chemical Engineering University of Puerto Rico-1994