Anisha Chaudhary
About Anisha Chaudhary
Anisha Chaudhary is a Clinical Quality Assurance professional with extensive experience in the biotech and biopharma industries. She has worked for several companies, including Takeda, Deciphera Pharmaceuticals, and Mirum Pharmaceuticals, and possesses strong knowledge of FDA regulations and quality management systems.
Current Role at Mirum Pharmaceuticals
Anisha Chaudhary currently serves as a Clinical Quality Assurance professional at Mirum Pharmaceuticals, Inc. She has been in this position since 2022, contributing to the company's commitment to maintaining high standards in clinical quality. Her role involves ensuring compliance with regulatory requirements and implementing quality management systems to support clinical trials and drug development processes.
Previous Experience in Quality Assurance
Anisha has a diverse background in clinical quality assurance, having worked at several notable companies. She was a Quality Compliance Specialist III at Takeda for six months in 2020. Following that, she served as a Senior Clinical Quality Specialist at Deciphera Pharmaceuticals from 2021 to 2022. Additionally, she worked as a Clinical Quality Assurance Specialist at Shire for five months in 2018 and as a Clinical Quality Specialist III at Ocular Therapeutix, Inc. from 2020 to 2021.
Educational Background
Anisha Chaudhary holds a Master of Science in Project Management with a concentration in Clinical Research and Drug Regulatory Affairs from Northeastern University, which she completed from 2017 to 2019. She also earned a Bachelor of Pharmacy from the University of Mumbai, studying from 2011 to 2015. Her educational background provides her with a strong foundation in both pharmaceutical sciences and regulatory compliance.
Expertise in Quality Management Systems
Anisha possesses in-depth knowledge of FDA regulations and the New Drugs and Clinical Trial Rules 2019 in India. She is skilled in Good Documentation Practices and Quality and Risk Management within the biotech and biopharma industries. Anisha has expertise in implementing and managing Quality Management Systems using software such as Veeva Vault, Master Control, and Trackwise. She is experienced in handling Trial Master Files and conducting regulatory inspections.
Career Development and Skills
Anisha's career began at Tata Consultancy Services, where she worked as a Quality/Regulatory Affairs Specialist from 2015 to 2017. This role laid the groundwork for her subsequent positions in clinical quality assurance. Her skills include thorough knowledge of quality compliance, risk management, and documentation practices, which are essential for ensuring the integrity of clinical trials and adherence to regulatory standards.