Jose Rivera

Strategic and results-driven leader with extensive experience in Quality Assurance (QA) and

Information Systems (IS) within the life sciences industry. Proven expertise in GxP systems, IT compliance, computer system validation (CSV), computer software assurance (CSA), data integrity, and audit readiness. Adept at developing risk-based compliance strategies to optimize operational efficiency while ensuring regulatory excellence. Passionate about leveraging technology to drive innovation in pharmaceutical and healthcare settings

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