VP, AI Quality Innovation @ Ziqqur (March 2026 - Present)
Director, IT Quality, Regulatory and Validation Technologies @ (January 2020 - March 2026)
Senior Manager, IT Quality – Computer System Validation @ (January 2018 - January 2020)
Senior Manager, Quality Systems @ (October 2015 - December 2017)
Quality Assurance Data Systems Manager @ (June 2013 - October 2015)
Lead Quality Systems Analyst @ (August 2006 - June 2012)
Quality Systems and Compliance Specialist @ (August 2004 - August 2006)
QC Analyst and Sample Coordinator @ Abgenix Inc. (now Boehringer Ingelheim) (September 2002 - August 2004)
Extrusion Lab Administrator @ (April 1999 - June 2000)
Government Property Administrator and Document Control and QC and Payroll @ (October 1994 - October 1998)
Shelly Lapointe Education
Ashford University
MA (Educational/Instructional Technology)
2008-2010
University of California, Santa Cruz
Certificate (Biotechnology)
2004-2005
San José State University
BS (Biology & Chemistry)
2000-2002
De Anza College
Chemistry
1993-1999
University of California, Santa Cruz
Biology
1992-1993
Shelly Lapointe Skills
21 CFR Part 11
AI Agents
Active DoD Secret Clearance
Aerospace Engineering
Aerospace Manufacturing
Artificial Intelligence (AI)
Artificial Intelligence for Business
Change Control
Computerized System Validation (CSV)
Data Integrity
Director level
Document Management
Equipment Qualification
External Audits
GAMP
Generative AI
Good Manufacturing Practice (GMP)
Information Technology Infrastructure
Large Language Models (LLM)
Mammalian Cell Culture
Manufacturing Quality
Medical Device Manufacturing
Medical Device Quality Assurance
Monoclonal Antibodies
Prompt Engineering
Quality Assurance
Quality Control
Quality System
Site Inspections
Stability Studies
Team Coordination
Trusted Business Partner
U.S. Department of Defense
Validation
Perseverance
Determination
Problem Solving
Livelink
SAP
SharePoint
Documentum
Six Sigma
LIMS
Bioassay
Technical Training
FDA
Software Documentation
Pharmaceutical Industry
Trackwise
Biopharmaceuticals
Medical Devices
HPLC
CAPA
GMP
SOP
Biotechnology
GLP
Life Sciences
Technology Transfer
Computer System Validation
Laboratory
Management
GxP
R&D
V&V
Standard Operating Procedure (SOP)
Laboratory Information Management System (LIMS)
Corrective and Preventive Action (CAPA)
Good Laboratory Practice (GLP)
U.S. Food and Drug Administration (FDA)
Quality Auditing
Cross-functional Team Leadership
Regulatory Affairs
Pharmaceutics
Clinical Trials
Testing
U.S. Title 21 CFR Part 11 Regulation
Standard Operating Procedure Sop
Strategic Planning
Process Improvement
Microsoft Excel
u.s. Food and Drug Administration Fda
Cross Functional Team Leadership
Good Laboratory Practice Glp
Corrective and Preventive Action Capa
Quality Systems
Laboratory Information Management System Lims
Standard Operating Procedure
Laboratory Information Management System
Corrective and Preventive Action
u.s. Food and Drug Administration
Good Laboratory Practice
Shelly Lapointe Summary
Shelly Lapointe, based in San Diego, CA, US, is currently a Co-Chair, Education Committee at Quality Champions for Life. Shelly Lapointe brings experience from previous roles at Ziqqur, Thermo Fisher Scientific and Pacira Pharmaceuticals, Inc.. Shelly Lapointe holds a 2008 - 2010 MA in Educational/Instructional Technology @ Ashford University. With a robust skill set that includes 21 CFR Part 11, AI Agents, Active DoD Secret Clearance, Aerospace Engineering, Aerospace Manufacturing and more. Shelly Lapointe has 1 mobile phone numbers on RocketReach.
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