Travis Chamberlain
Director, Development QA at Denali
- Role
- Director, Development Qa at Denali Therapeutics
- Location
- Novato, CA, US
- LinkedIn followers
- 500 followers
About Travis Chamberlain
Registered QA Professional-GLP (RQAP-GLP) with experience in GCP and GLP auditing and program support.Previous experience includes:GxP Regulatory Authority Inspection Preparation and ManagementGCP External Auditing -Clinical Investigator Sites-CROs-Specialty Labs-Software VendorsClinical Program Compliance SupportGLP and GCP Internal/External Facility/Vendor Compliance Assessments against-FDA, ICH, and International GCP-FDA 21CFR58-OECD GLP-JMHLW-FDA 21CFR11-Current Industry Standards and Agency ExpectationsGLP QA Systems Implementation and Management-QA Inspection and Reporting Procedures-Auditing Metrics, Management Notification Systems, Master Schedule-GLP Roles and Responsibilities-Deviation, Unexpected Event, and Investigation Processes-Staff Development, Training, and RetentionGLP and GCP Study-Based Auditing, Training, Supervision, and Planning-Bioanalytical-Immunoanalytical-Dose Formulation Analysis-Method Validation-PK/TK Modeling -In-Life Study In-Process, Data and Reporting-Clinical Study Reports
Experience
Director, Development Qa
May 2024 — Present
Education
University of Oregon
BA, Biology - Molecular, Cellular, Developmental Specialty
1999 — 2003
Skills
- Glp
- Capa
- CRO
- Gxp
- 21 Cfr Part 11
- Good Laboratory Practice (Glp)
- Sop
- Fda
- Validation
- Life Sciences
- Good Clinical Practice (Gcp)
- Biotechnology
- Gcp
- Computer System Validation
- Quality Assurance
- Gmp
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