Gaurav Walia

With over 28 years of experience in the pharmaceutical and medical device industry, I am a passionate and driven leader who strives to deliver excellence in compliance, quality, and regulatory affairs.

As the Vice President of CSV/CSA/DI and Digital Governance and Sr. Associate Partner at PQE Group, I oversee 60+ direct reports globally and provide strategic guidance and solutions for computerized system validation, computer software assurance, and data integrity across various business units and functions.

I have a strong background in laboratory management, technology implementation, software design, budgeting, and international regulatory agencies.

I have successfully designed and managed 200,000+ sq.ft. laboratories, implemented safety and training programs, and handled the entire materials import process for APIs, drugs, intermediates, etc.

I am also an international speaker and trainer for KENX Conferences and Adjunct Lecturervfor Temple University Master’s QA/RA Program and regularly speak and/or attend conferences for PDA, ISPE, ASQ, Institute of Validation Technology, etc. in sharing my insights and expertise on Emerging Quality, Compliance and Regulatory trends as well as innovative updates on technology, AI, Cybersecurity, investigations/CAPAs with Enterprise , Quality, Laboratory, Packaging , Environmental and Manufacturing systems.

I been a part of Major Consent Decree Projects focusing on CSV/DI and Remediation.

I enjoy collaborating with diverse teams and stakeholders, and empowering them to achieve Augmented Success with Quality, Compliance and Regulatory objectives. Plan to achieve common goals and improve business practices.