Senior Director, Development Quality
Current
Feb 2024 - Present
AeroLeads people directory · profile
Devon Hyatt Email & Phone Number
Clinical Quality Assurance Professional
at
Denali Therapeutics
1 work email found
@gene.com
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Clinical Quality Assurance Professional
Location
San Francisco Bay Area, United States, United States
Who is Devon Hyatt? Overview
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Quick answer
Devon Hyatt is listed as Clinical Quality Assurance Professional at Denali Therapeutics, based in San Francisco Bay Area, United States, United States. AeroLeads shows a work email signal at gene.com and a matched LinkedIn profile for Devon Hyatt.
Devon Hyatt previously worked as Senior Director, Development Quality at Denali Therapeutics and Director, Development Quality at Denali Therapeutics. Devon Hyatt studied at Science Leadership Program, Genentech.
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{last}.{first}@gene.com
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Profile bio
About Devon Hyatt
I am a Quality & Compliance professional who has worked successfully in both clinical and industry settings on a wide variety of drug and device studies in late and early stage development. I guide cross-functional research teams to identify, maintain, and simplify their GCP/GVP processes. Using a customer focused approach, I develop my people and teams, while also building productive relationships with key stakeholders. I drive solutions that make compliance practical, achievable, and transparent in deadline driven environments.
Listed skills include Gcp, Biotechnology, Medical Devices, Regulatory Affairs, and 20 others.
Current workplace
Devon Hyatt's current company
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9 roles · 22 years
Devon Hyatt work experience
A career timeline built from the work history available for this profile.
Director, Development Quality
Sep 2019 - Feb 2024
Principal Manager, Quality And Compliance Office Gred Early Development
-Ensure the delivery of a robust Quality Management System (QMS) to support GCP/GVP activities within early clinical development.-Landscape, plan, and execute global medical and healthcare compliance quality management activities including development of the annual Quality Plan and Handbook for ECD.-Lead team to identify and implement continuous.
Jan 2018 - Sep 2019
Process Excellence Leader, Gcp/Gvp
-Create an improvement and oversight strategy for GCP/GVP global processes.-Analyze audit/inspection and other data to identify and anticipate process related risks.-Navigate and influence at all levels of a complex matrix organization.-Lead and build cross-functional teams to drive process improvements.-Foster strong relationships with key business.
Apr 2016 - Dec 2017
Principal Quality Specialist
Managed the development of GCP/GVP-regulated policies, SOPS, and businessprocesses. Carried out expedited updates per agreed timelines.-Provided leadership, project management to cross-functional teams.-Partnered with training colleagues to define GCP/GVP training strategies.-Identified hundreds of old processes that were noncompliant with the.
Sep 2015 - Apr 2016
Sr. Quality Specialist (Standards And Process Governance)
Implement a controlled document strategy. Support establishment of GxP Standards through Policies and SOP development to ensure a consistent document landscape for standards and processes related to clinical development and safety/pharmacovigilance. Build and maintain strong relationships with key business stakeholders and identify needs for process.
Jul 2012 - Sep 2015
Regulatory And Compliance Coordinator
- Manage and track detailed regulatory issues for more than 100 phase II-IV drug and device clinical trials.
- Conduct internal audits and assist in development of quality management program, including the creation and implementation of a deviation tracking and resolution program.
- Support CAPA activities by leading research teams through Root Cause Analysis, creation of schedules, and further regulatory training where needed.
- Develop trainings with clinical staff, sponsors, and regulatory bodies in order to promote compliance.
Oct 2007 - May 2012
Clinical Research Coordinator
Veterans Hospital
- Develop new protocols, SOPs, and grants to initiate novel FDA regulated clinical trials in Research & Development at the VA.
- Responsible for all IRB submissions and patient record maintenance for protocols.
- Oversee and facilitate new research, train new staff.
Jul 2006 - Jul 2007
Clinical Research Associate
- Monitor sites to make sure data is within GCP and IHC guidelines through out the duration of global phase II, III and IV clinical trials.
- Analyze data according to SOP.
- Co-prepare and distribute study specific documentation and materials.
- Certify and train technologists for study participation.
- Delegate tasks to research assistants and provide training for other study team members.
- Write SOPs, training presentations, and design reports for Sponsor.
2004 - 2007
~3 yrs
3 education records
Devon Hyatt education
Education record
Science Leadership Program, Genentech
Ms, Regulatory Affairs
San Diego State University
Ba, Psychology
Lewis & Clark College
FAQ
Frequently asked questions about Devon Hyatt
Quick answers generated from the profile data available on this page.
What company does Devon Hyatt work for?
Devon Hyatt works for Denali Therapeutics.
What is Devon Hyatt's role at Denali Therapeutics?
Devon Hyatt is listed as Clinical Quality Assurance Professional at Denali Therapeutics.
What is Devon Hyatt's email address?
AeroLeads has found 1 work email signal at @gene.com for Devon Hyatt at Denali Therapeutics.
Where is Devon Hyatt based?
Devon Hyatt is based in San Francisco Bay Area, United States, United States while working with Denali Therapeutics.
What companies has Devon Hyatt worked for?
Devon Hyatt has worked for Denali Therapeutics, Genentech, Kaiser Permanente Center For Health Research, Veterans Hospital, and Synarc.
How can I contact Devon Hyatt?
You can use AeroLeads to view verified contact signals for Devon Hyatt at Denali Therapeutics, including work email, phone, and LinkedIn data when available.
What schools did Devon Hyatt attend?
Devon Hyatt studied at Science Leadership Program, Genentech.
What skills is Devon Hyatt known for?
Devon Hyatt is listed with skills including Gcp, Biotechnology, Medical Devices, Regulatory Affairs, Irb, Sop Development, Quality Systems, and Regulatory Compliance.
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