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Tara T.

Director, Quality Systems And Compliance at Karuna Therapeutics

Tara T. has a wealth of experience in the field of quality assurance and compliance. Tara currently holds the position of Director of Quality Systems and Compliance at Karuna Therapeutics, where they lead the implementation of quality system processes and operations to ensure the highest level of compliance. Their role also includes participating in internal and supplier quality audits, supporting document control, training, records management, and computer system validation. Tara joined Karuna Therapeutics in 2022.

Prior to their current role, Tara worked at ImmunoGen, Inc. as an Associate Director of GMP Audits & General Compliance. Here, they managed the internal and external auditing programs and contributed to the improvement and maintenance of the company's internal GMP Quality System. Tara also served as the Internal QA for all non-product specific records and was involved in new product labeling and commercial supplier selection. Tara was with ImmunoGen, Inc. from 2020 to 2022.

Before joining ImmunoGen, Inc., Tara worked at AMAG Pharmaceuticals from 2017 to 2020. During their time there, they held various positions including Senior Manager of Quality Compliance & Quality Systems, Senior Manager of Quality Assurance Operations & Product Complaints, and Manager of Quality Assurance Operations & Product Complaints. In these roles, they were responsible for maintaining oversight and management of the Quality Compliance program, coordinating GxP Vendor Management, facilitating the components of the Quality Management System, and overseeing critical operations within the commercial and clinical supply chain.

From 2013 to 2017, Tara worked at Alexion Pharmaceuticals, Inc. as a QA Team Lead and QA Specialist II. In these roles, they served as the primary QA contact for various manufacturing areas, reviewed and assessed deviations, and authored and reviewed procedures and batch records.

Tara's experience also includes roles at Lonza Biologics, Shire HGT, Antigenics, Inc., GTC Biotherapeutics, and AstraZeneca, where they gained expertise in quality assurance, document control, training, and compliance.

Overall, Tara T. has a comprehensive background in quality assurance and compliance, with a focus on implementing quality systems, conducting audits, and ensuring compliance with regulatory requirements.

Tara T. obtained their Associate of Science degree in Computer Information System with a Programming Concentration from Quinsigamond Community College from 2001 to 2005. Tara then pursued a Bachelor of Science degree in Business Administration with a Management Concentration from Becker College from 2005 to 2007. In addition to their degrees, Tara T. also obtained certifications as a Certified Quality Technician from ASQ - World Headquarters in October 2015 and as a Certified Quality Auditor from the same institution in December 2018.

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