2026 -
now Vice President, Global Regulatory Policy and Scientific Affairs @
2024 -
2026 Senior Director, Global Regulatory Policy @
2022 -
2023 Senior Director, Global Regulatory Affairs @
2018 -
2022 Senior Director, Quality and Regulatory Control @
2013 -
2018 Director, Regulatory and Quality Compliance @
2010 -
2013 Director Quality Control @
2006 -
2010 Manager, QC Microbiology and Biology Departments @
2005 -
2006 Senior Research Scientist @ en-N-tech Inc
2003 -
2005 Research Scientist @ aLF Ventures LLC
1999 -
2000 Research Assistant @ South Bank University
1997 -
1998 Research Assistant @
James Knowles Education
London South Bank University
Ph.D. (Microbiology)
1999
-
2002
London South Bank University 1999
-
2002
University of Lincoln
BSc (Environmental Science)
1994
-
1997
James Knowles Skills
Relationship Building
Analytical Skills
Data Management
Communication
Policies & Procedures Development
Coaching & Mentoring
510(k)
Health Canada
Global Regulatory Compliance
Continuous Improvement
Quality Analytics
Equipment and Computer Systems Validation
Leadership
Supplier Quality Management
Team Restructuring
Biologics
Quality Management Systems
Quality Risk Management
FDA, EMA/EU, Health Canada regulations and submission processes
Collaborative Leadership Approach
Quality Management
Microbiology
FDA
GMP
Quality Control
Validation
Quality Auditing
Pharmaceutical Industry
Regulatory Submissions
21 CFR Part 11
CAPA
Regulatory Affairs
Quality Assurance
Change Control
GxP
Aseptic Processing
Biopharmaceuticals
Technology Transfer
SOP
Standard Operating Procedure (SOP)
Good Laboratory Practice (GLP)
Regulatory Requirements
Clinical Laboratory Improvement Amendments (CLIA)
European Medicines Agency
U.S. Title 21 CFR Part 11 Regulation
Regulatory Compliance
Cross-functional Team Leadership
FDA GMP
EMA
Quality System Compliance
Pharmaceuticals
laboratory management
Life Sciences
QC
Molecular Biology
Raw Materials
Quality System
Laboratory
Lifesciences
Chromatography
Cleaning Validation
LAL
GLP
V&V
LIMS
Regulatory
Strategic Planning
Compliance
Operations
Research
Clinical Laboratory Improvement Amendments Clia
Corrective and Preventive Action Capa
Cell Culture
Biochemistry
Standard Operating Procedure Sop
Customer Service
u.s. Food and Drug Administration Fda
PowerPoint
Biotechnology
Good Laboratory Practice Glp
Science
Pharmaceutics
Cross Functional Team Leadership
Standard Operating Procedure
Corrective and Preventive Action
u.s. Food and Drug Administration
Good Laboratory Practice
Clinical Laboratory Improvement Amendments
James Knowles Summary
James Knowles, based in Los Angeles, CA, US, is currently a Vice President, Global Regulatory Policy and Scientific Affairs at Plasma Protein Therapeutics Association (PPTA). James Knowles brings experience from previous roles at Plasma Protein Therapeutics Association (PPTA) and Grifols. James Knowles holds a 1999 - 2002 Ph.D. in Microbiology @ London South Bank University. With a robust skill set that includes Relationship Building, Analytical Skills, Data Management, Communication, Policies & Procedures Development and more. James Knowles has 2 emails and 2 mobile phone numbers on RocketReach.
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