Deborah Toyota
Director, R&D Quality & Compliance
- Role
- Quality Lead, Biogen West at Biogen
- Location
- Windham, CT, US
- LinkedIn followers
- 500 followers
About Deborah Toyota
Familiar with regulatory requirements for FDA, MHRA, EMA, PMDA and other agencies. Experienced in various aspects of quality investigation, risk management and CAPA. Expertise facilitating inspection readiness and management activities. Seasoned manager of both full-time staff and functional service contractors.
Experience
Quality Lead, Biogen West
Sep 2024 — Present
Responsible for Biogen Nephrology Research and Development Quality Management System (QMS) strategy and execution globally including quality risk management, quality culture and processes, and quality data and analytics. This includes quality and compliance elements covering Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), Good Research Practice (GRP) and Good Pharmacovigilance Practice (GVP).
Education
Northeastern University
MS, Engineering Mgmt, CIS
University of Rhode Island
BS, Industrial/Manufacturing Engineering
Skills
- Clinical Research
- Quality Assurance
- Standard Operating Procedure (Sop)
- Gmp
- Edc
- Quality System
- Sas Programming
- 21 Cfr Part 11
- Gcp
- U.s. Title 21 Cfr Part 11 Regulation
- Quality Auditing
- Validation
- Oncology
- Pharmaceutical Industry
- Sop
- Data Management
- Clinical Data Management
- Electronic Data Capture (Edc)
- Clinical Trials
- Vaccines
- Cardiology
- Good Clinical Practice (Gcp)
- CRO
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.