Viral Soni

Quality & Compliance executive with 15+ years of progressive leadership in FDA-regulated generic pharmaceutical manufacturing. More than 8 years leading Quality organizations with responsibility for Quality Assurance, Quality Control, Validation, Compliance, Document Control, Training, Supplier Quality, Internal Audits, Stability, Warehouse Quality, Serialization and Digital Transformation. Successfully led seven FDA inspections, including the last three inspections completed with zero Form FDA 483 observations.

Extensive experience implementing enterprise quality systems, driving inspection readiness, leading cross-functional teams, managing regulatory licensing across approximately 18 U.S. states, and modernizing quality operations through PRAGMA eQMS, Caliber LIMS, SAP ERP and an internally designed AI-powered Regulatory License Management Platform.

Director – Quality Management & Compliance - Ingenus Pharmaceuticals NJ, LLC

(2022-01)

Provide strategic leadership for the site Quality Management System and oversee Quality Assurance, Quality Control, Validation, Compliance, Training, Document Control, Supplier Quality, Stability, Warehouse QA and Serialization. Direct quality oversight for commercial manufacturing operations involving tablets, capsules, powders and nasal spray products. Exercise quality authority for batch disposition, investigations, deviations, CAPA, change controls, complaints, Annual Product Reviews, validation documentation and high-level GMP records.

Partner with Manufacturing, Engineering, Supply Chain, Warehouse and Regulatory Affairs to ensure compliant production, storage and distribution.

• Lead FDA, DEA, DEP, customer and third-party inspections while maintaining continuous inspection readiness.
• Successfully led the last three FDA inspections with zero Form FDA 483 observations.
• Manage pharmaceutical licenses and regulatory permits across approximately 18 U.S. states including manufacturing licenses, DEA registrations, EPA/DEP, hazardous waste, fire, water and air permits.
• Implemented PRAGMA electronic Quality Management System (eQMS), digitizing deviations, CAPA, change control, document control and quality workflows to improve efficiency and compliance.
• Led evaluation, implementation, validation and deployment of Caliber LIMS. Directed a 9-month business process assessment and successful implementation of 13 integrated modules including stability, reference standards, columns, training and instrument management.
• Implemented QR-code based laboratory workflows, eliminated paper laboratory notebooks, enabled tablet-based documentation and significantly improved laboratory efficiency and data integrity.
• Led SAP ERP implementation supporting inventory control and compliant business processes.
• Designed and developed an AI-powered cloud Regulatory License Management Platform featuring automated renewal reminders, document vault, executive dashboards and centralized compliance tracking.

Associate Director – Quality Assurance - Ingenus Pharmaceuticals NJ, LLC

(2018-01 - 2021-12)

Manager / Sr. Manager – Quality Assurance - Ingenus Pharmaceuticals NJ, LLC

(2015-01 - 2017-12)

QA/RA Associate - Mirror Pharmaceuticals

(2011-01 - 2015-12)

Product Development & Technical Services Associate - US Pharma Lab Inc.

(2010-01 - 2011-12)

M.S. - Pharmaceutical Manufacturing - Stevens Institute of Technology

Bachelor - Pharmacy - Rajiv Gandhi University