Jiten A
Director of Quality Assurance at Natera | Dublin, California, United States
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Jiten A. serves as the Director of Quality Assurance at Natera, where he leverages his extensive expertise in software quality assurance and regulatory compliance to ensure the highest standards in scientific computing applications and in vitro diagnostic (IVD) software. With a strong focus on Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), Jiten is instrumental in overseeing the validation of computerized systems, ensuring adherence to critical regulations such as 21 CFR Part 11 and Part 820, as well as ISO 13485, 62304, and 14971. His role involves leading comprehensive software verification and validation (V&V) processes, managing design controls, and facilitating FDA premarket approval (PMA) submissions, which are pivotal for the successful launch of innovative diagnostic solutions.
Jiten's leadership is characterized by his goal-oriented approach and exceptional communication skills, which he employs to foster collaboration across cross-functional teams. His experience in merger and acquisition (M&A) initiatives has equipped him with a unique perspective on systems, processes, and people transformation, allowing him to effectively manage the integration of quality management systems during transitions. Key projects under his guidance have included rigorous software supplier audits and pharmaceutical partner evaluations, ensuring that all external collaborations meet Natera's stringent quality standards.
In addition to his auditing and project management capabilities, Jiten excels in requirements analysis and test planning, utilizing cost-effective methods to enhance operational efficiency. His commitment to quality management not only safeguards compliance but also drives continuous improvement within the organization, positioning Natera as a leader in the rapidly evolving landscape of genetic testing and diagnostics.
Director of Quality Assurance at Natera in September 2023 to Present
Sr IT Program Manager (GxP CSV Quality) at AstraZeneca in April 2019 to March 2024
CSV & Application Mgr at Portola Pharmaceuticals in August 2018 to April 2019
Sr Project Validation Mgr at Bayer in December 2016 to June 2018
Senior Manager/Head of Systems & Process Validation at Pacific Biosciences in December 2014 to August 2016
Sr. Project Validation Lead/Manager at Intuitive Surgical in November 2013 to December 2014
Sr. Validation Team Lead at Novartis Vaccines and Diagnostics in June 2007 to November 2013
Sr Validation Engineer at Boston Scientific in February 2006 to May 2007
Validation Engineer at Johnson & Johnson in September 2004 to December 2005
Business Analyst at System Domain in June 2000 to December 2001
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CUNY CSI College, New York, USA, June 2026
T John College, Bangalore, India, June 1996 to June 2026
Kendriya Vidyalaya, High School, June 1994 to June 1996
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FDA GMP
Part 820
Internal Audits
External Audits
Computerized System Validation (CSV)
Corrective and Preventive Action (CAPA)
Vendor Management
Project Commissioning
Business Analysis
Project Delivery
Auditing
Change Management
Infrastructure
Software Quality Assurance
Project Management
Good Manufacturing Practice (GMP)
Validation
Quality Systems
SAP
Testing
Test Planning
LIMS
Quality Management
21 CFR Part 11
Computer System Validation
GAMP
GxP
SDLC
FDA
Requirements Analysis
Documentation
Document Management
Software Documentation
Medical Devices
GLP
ISO 13485
Sop
Quality System
V&V
SOP
Laboratory Information Management System (LIMS)
U.S. Title 21 CFR Part 11 Regulation
U.S. Food and Drug Administration (FDA)
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Discover more about NateraWhat is Jiten A email address?
Email Jiten A at [email protected]. This email is the most updated Jiten A's email found in 2026.
How to contact Jiten A?
To contact Jiten A send an email to [email protected]. (updated on September 04, 2024)
What company does Jiten A work for?
Jiten A works for Natera
What is Jiten A's role at Natera?
Jiten A is Director of Quality Assurance
What is Jiten A's Phone Number?
Jiten A's phone (213) ***-*343
What industry does Jiten A work in?
Jiten A works in the Biotechnology industry.
Jiten A Email Addresses
Jiten A Phone Numbers
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