George Tkhinvaleli
Senior Director Quality Assurance at Harpoon Therapeutics | Austin, Texas Metropolitan Area
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George Tkhinvaleli serves as the Senior Director of Quality Assurance at Harpoon Therapeutics, where he plays a pivotal role in ensuring the integrity and compliance of clinical development processes. With a robust background in Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance (GPV), George has successfully built and led dynamic Quality teams that are dedicated to fostering a culture of quality across the organization. His expertise lies in developing and implementing comprehensive Quality Management Systems (QMS) that not only meet regulatory standards but also enhance operational efficiency.
At Harpoon Therapeutics, George is instrumental in establishing a risk-based GxP compliance program, which includes conducting thorough audits of clinical investigator sites both within the U.S. and internationally. His strategic oversight extends to the management of GxP Vendor Management Systems, ensuring that all external partners adhere to the highest quality standards. George's proficiency in auditing, particularly in the context of oncology clinical trials, allows him to identify potential compliance gaps and implement corrective actions effectively.
In addition to his auditing responsibilities, George is adept at supporting internal systems and processes across various functional groups, which is crucial for the success of ongoing clinical trials. His familiarity with regulatory frameworks, including U.S. Title 21 CFR Part 11, positions him as a key resource for navigating the complexities of clinical development. With a focus on continuous improvement, George is committed to advancing the quality landscape at Harpoon Therapeutics, ultimately contributing to the successful delivery of innovative therapies to patients.
Senior Director Quality Assurance at Harpoon Therapeutics in April 2023 to Present
Senior Director, Clinical Quality Assurance at Deciphera Pharmaceuticals in March 2022 to April 2023
Senior Director, GCP Quality at Talaris Therapeutics in June 2021 to March 2022
Director, Head of GCP Quality Assurance at Aeglea BioTherapeutics in July 2016 to June 2021
GCP/GVP QA Consultant at Nova Eastern GxP Consulting in March 2015 to July 2016
Director, Head of GCP Quality Assurance at Pearl Therapeutics (AstraZeneca) in April 2011 to March 2015
Manager GCP/GLP Compliance at Forest Laboratories (Allergan) in February 2007 to April 2011
Sr. Auditor GCP Compliance at PharmaNet Development Group, Inc. in March 2005 to February 2007
Quality Officer at PAREXEL, Phase I Clinical Pharmacology Research Unit in April 2003 to March 2005
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Quality Auditing
Auditing Standards
Pharmacovigilance
GDPR
Quality Risk Management
SOP development
Process Improvement
Gap Analysis
Operational Planning
GCP
Clinical Research
Auditing
Clinical Trials
Pharmaceutical Industry
GxP
21 CFR Part 11
Regulatory Submissions
Computer System Validation
Clinical Development
Regulatory Affairs
FDA
CAPA
GLP
Biotechnology
Trackwise
PAI readiness
Six Sigma
IND
Sop
CRO
CTMS
Regulatory Requirements
Clinical Data Management
Quality System
Change Control
SOP
Validation
ICH-GCP
Oncology
Quality Assurance
Drug Development
Therapeutic Areas
Standard Operating Procedure (SOP)
U.S. Food and Drug Administration (FDA)
CRO Management
U.S. Title 21 CFR Part 11 Regulation
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Clinical Trial Management System (CTMS)
Corrective and Preventive Action (CAPA)
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Discover more about Harpoon TherapeuticsWhat is George Tkhinvaleli email address?
Email George Tkhinvaleli at [email protected] and [email protected]. This email is the most updated George Tkhinvaleli email found in 2026.
What is George Tkhinvaleli phone number?
George Tkhinvaleli phone number is +14436228585.
How to contact George Tkhinvaleli?
To contact George Tkhinvaleli send an email to [email protected] or [email protected]. If you want to call George Tkhinvaleli try calling on +14436228585. (updated on November 04, 2024)
What company does George Tkhinvaleli work for?
George Tkhinvaleli works for Harpoon Therapeutics
What is George Tkhinvaleli's role at Harpoon Therapeutics?
George Tkhinvaleli is Senior Director Quality Assurance
What industry does George Tkhinvaleli work in?
George Tkhinvaleli works in the Pharmaceutical Manufacturing industry.
George Tkhinvaleli Email Addresses
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