Piyush Upadhyay

A highly experienced Project Manager and GxP Specialist with over a decade of experience in managing and implementing electronic Quality Management Systems (eQMS) in the life sciences sector. I have extensive expertise in configuring and maintaining Veeva Vault platforms, including QualityDocs and QMS Vault, ensuring regulatory compliance in highly controlled, traceable, and auditable GxP environments. My skill set also includes project leadership, audit readiness (including MHRA inspections), and the ability to drive continuous improvements in quality management systems. Proven ability to lead teams, partner with cross-functional business units, and ensure data integrity and compliance through proactive planning and system management.

• Successfully configured Veeva Vault applications for multiple life sciences clients, ensuring GxP compliance and improving process efficiency by 30%.
• Provided expert support during MHRA audits, ensuring systems were fully compliant with regulatory standards.
• Developed automated reporting and tracking tools to enhance system data integrity and regulatory alignment.

• Trackwise, Trackwise Digital and ZenQMS EQMS Software Certified
• Trackwise and Trackwise Digital Certified by Sparta System
• Salesforce Platform App Builder Trained by Salesforce
• Process Validation Trained, Project Management Fundamentals

• Veeva Vault Platform Expertise: Proficient in configuring and overseeing Veeva Vault QualityDocs and QMS Vault, ensuring alignment with GxP requirements and regulatory standards.
• GxP Environment Leadership: Led quality systems teams, managing eQMS systems in controlled, traceable, and auditable GxP environments. Developed workflows for CAPA, deviation handling, and change control.
• Regulatory Compliance & Inspection: Extensive experience in MHRA inspections, ensuring readiness of eQMS for audits. Oversaw system validation and compliance, particularly in regulated environments.
• Project Leadership & Continuous Improvement: Led large-scale global projects, ensuring alignment with organizational quality roadmaps, driving process improvements, and managing Veeva platform upgrades.
• System Integrity & Data Management: Ensured data integrity and system accuracy through proactive maintenance and upgrades while implementing validation protocols to ensure compliance across systems.
• Client Collaboration & Engagement: Partnered with business units to identify process gaps, recommend solutions, and improve eQMS functionalities through regular engagement, reporting, and providing metrics at quality review meetings.