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.
