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Brandy Lewis Location
Encinitas, CA, US
Brandy Lewis Work
2025 -now Senior Associate @
2025 -now Principal @ Lewis Quality Consulting LLC
2025 -now Owner @ Heaven's Little Ones
2024 -2025 Vice President, Quality Assurance @
2020 -2024 Vice President Quality Assurance @
2020 -2020 Vice President Quality Assurance @
2018 -2020 Senior Director, GMP Compliance @
2015 -2018 Principal Consultant @ Independent Consultant
2017 -2018 Senior Director of Quality Assurance @ Regulus Therapeutics
2015 -2016 Head and Senior Director of Quality Assurance @ Apricus Biosciences, Inc.
2014 -2015 Principal Quality Consultant and Director, Quality Consulting @
2013 -2014 Director of Quality Systems and Head of Quality @ Evofem and Cosmederm Biosciences
2013 -2013 Associate Director of Quality Systems @ Shire Regenerative Medicine
2010 -2013 Quality Systems Manager @ Shire Regenerative Medicine (formerly Advanced BioHealing)
2009 -2010 Quality Systems Manager @
2007 -2009 Associate Director of Quality Assurance and Compliance and Head of Quality @ Kalypsys
2005 -2007 Associate Director of Quality Assurance and Compliance @
2002 -2004 Sr. Manager of Quality Assurance @ Favrille
1996 -2001 Manager of Quality Assurance and Compliance @ Agouron Pharmaceuticals
2000 -2001 Senior Manager, Quality Assurance and Compliance @
1992 -1996 Quality Control Sr. Research Associate @ DepoTech
Brandy Lewis Education
University of San Diego
BA (Chemistry)
1988-1992
Brandy Lewis Skills
GMP
Biotechnology
FDA
Technology Transfer
Pharmaceutical Industry
CAPA
Aseptic Processing
GLP
Lifesciences
Quality System
HPLC
Sop
Validation
Change Control
Analytical Chemistry
21 CFR Part 11
Computer System Validation
V&V
Regulatory Affairs
Biopharmaceuticals
Quality Auditing
Medical Devices
Quality Control
Batch Records
GxP
Regulatory Submissions
Quality Assurance
ISO 13485
Clinical Trials
IND
Drug Development
Biologics
Trackwise
cGMP manufacturing
GAMP
GCP
Life Sciences
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
Standard Operating Procedure (SOP)
Auditing
Obtain
Leaves
Policy
Life Insurance
Reporting
Cfra
Unemployment
Team Building
Business Intelligence
Employee Relations
Management
Reports
COBRA
Disability Insurance
Leave of Absence
Payroll
Automatic
Contract Negotiation
Leadership
Business Administration
Public Speaking
Employee Engagement
Corrective and Preventive Action Capa
State Laws
Legal
Deferred Compensation
Logistics
Human Resources
Pdl
Sales Management
Microsoft Word
Talent Acquisition
Project Management
Inventory Management
Microsoft Excel
ADP Payroll
Written
Americans with Disabilities Act
System
Compensation
Leasing
Communication
QuickBooks
Forecasting
New Business Development
Carriers
Medicine
Redwood
Concepts
Claim
Microsoft Office
Visual Merchandising
Hearings
Marketing Strategy
SPHR
Performance Management
New Hires
Eligibility
Payroll Services
FMLA
Healthcare
Hiring
Employee Benefits
Interpreting
Mitsubishi
PowerPoint
Onboarding
Change Management
Delivering Presentations
Short
Social Media
Distribution
Sales
Retail
Forms
Standard Operating Procedure Sop
Materials
Coaching
Invoicing
Staff Development
Clerical
Coordinate
Usa
Policies and Procedures
International
Event Planning
HR Policies
New Hire Processing
Workers Compensation
Leadership Development
Customer Service
Disabilities
u.s. Food and Drug Administration Fda
Strategic Planning
Automobile
Dentistry
Benefits Administration
Supervision
HRIS
Informing
Recruiting
401k
Talent Management
Organizational Structure
Open Enrollment
Administrative Assistance
Good Laboratory Practice Glp
Standard Operating Procedure
u.s. Food and Drug Administration
Corrective and Preventive Action
Good Laboratory Practice
Brandy Lewis Summary
Brandy Lewis, based in Encinitas, CA, US, is currently a Senior Associate at Jeff Yuen & Associates, Inc.. Brandy Lewis brings experience from previous roles at Lewis Quality Consulting LLC, Heaven's Little Ones, Kailera Therapeutics and Kura Oncology, Inc.. Brandy Lewis holds a 1988 - 1992 BA in Chemistry @ University of San Diego. With a robust skill set that includes GMP, Biotechnology, FDA, Technology Transfer, Pharmaceutical Industry and more. Brandy Lewis has 2 emails and 4 mobile phone numbers on RocketReach.
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