PQE Group
VP of CSV/CSA/DI & Digital Governance, Head of Chicago, & Local Equity Partner
Harvinder Walia is VP of CSV/CSA/DI and Digital Governance, Head of the PQE Chicago Office, and Local Equity Partner at PQE Group. He also serves as Adjunct Lecturer in the RA/QA Graduate Program at Temple University School of Pharmacy.
With over 28 years of experience across pharmaceutical, medical device, and consumer healthcare sectors, Mr. Walia brings deep expertise in CSV, computer software assurance, data integrity, automation, ML/AI, cleaning validation, QMS, and IT infrastructure qualification. He has led end-to-end validation and qualification programs spanning laboratory, manufacturing, and enterprise systems, with broad experience in audit execution, gap remediation, and vendor compliance assessments.
He has participated in more than 100 FDA audits and inspections and led three major consent decree projects focused on CSV and data integrity. An active PDA and ISPE member, he serves as Founding Member and 2026 incoming Chair of the Global MentorISPE Committee, and contributes to the Digital Validation Committee and multiple AI-focused Communities of Practice. He is also an Executive Advisory Board Member for IVT/Informa, a contributing expert for KENX, and Vice Chairman of the ASQ Chicago Section.
