Sushil Kukadia

Sushil Kukadia

Senior Manager, Quality Compliance Apac At Bei Gene @ BeiGene

About Sushil Kukadia

Sushil Kukadia is the Senior Manager of Quality Compliance - APAC at BeiGene in New Delhi, India, with extensive experience in quality assurance and clinical research management.

Current Position at BeiGene

Sushil Kukadia currently serves as Senior Manager, Quality Compliance - APAC at BeiGene. He is based in the New Delhi area, India. At BeiGene, he handles quality compliance responsibilities for the Asia-Pacific region.

Previous Role at PPD

From 2019 to 2022, Sushil Kukadia worked at PPD as Compliance Manager - APAC, Quality Investigation & Support, Global Quality & Compliance. His role included overseeing quality investigations and providing support for compliance-related matters within the Asia-Pacific region. He was based in Adelaide, South Australia, Australia during this tenure.

Experience at AVANCE Clinical Pty Ltd and CPR Pharma Services Pty Ltd

Sushil Kukadia held the position of Senior Quality Assurance Associate at AVANCE Clinical Pty Ltd (formerly CPR Pharma Services Pty Ltd) in 2019 for 5 months in Adelaide, Australia. Before the rebranding, he worked at CPR Pharma Services Pty Ltd, also as a Senior Quality Assurance Associate, from 2017 to 2019, accumulating a total of 2 years and 5 months in Quality Assurance roles at these firms.

Role at Tech Observer

From 2014 to 2017, Sushil Kukadia served as Senior Manager and Head - Quality Assurance at Tech Observer in Adelaide, Australia. There, he was responsible for leading the quality assurance functions and guiding the team to meet compliance and quality standards.

Academic Background

Sushil Kukadia holds a Post Graduate Diploma in Clinical Research (PGDCR) from the Academy for Clinical Excellence, Bombay College of Pharmacy, which he completed between 2004 and 2005. Additionally, he earned a Master’s Degree in Pharmacy (M. Pharm.) - Quality Assurance from Sardar Patel University from 2000 to 2002, and a Bachelor’s Degree in Pharmacy (B. Pharm.) from the same institution, which he completed between 1995 and 2000.

Early Career Experience

Sushil Kukadia began his career at Chiltern as a Clinical Research Associate (CRA) from 2005 to 2006 in Mumbai Area, India. He later worked at Lambda Therapeutic Research Ltd in various roles, including Research Scientist - II, Clinical Trial Management, and Project Manager - Clinical Trial Management from 2006 to 2011 in the Ahmedabad Area, India. He also gained experience as a Clinical Research Associate (CRA) - II, at Covance from 2007 to 2009.

Professional Certifications and Audits

Sushil Kukadia has successfully hosted 12 US FDA inspections without any FDA 483s and cleared inspections from MHRA, ANVISA, and DCGI. He has conducted over 100 investigator site audits and more than 50 sponsor and certification audits. He is also experienced in delivering QMS projects with extensive SOPs across functions for global sponsors and has conducted various types of audits, including system, process, and gap analysis.

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