2007 -2012 Global QA Support, Principal Scientist, Quality Affiliates and Marketing @
2001 -2007 Diabetes Manufacturing QA Principal Scientist @
2000 -2001 Regulatory Affairs Officer @
1995 -2000 Pilot and Manufacturing Scientist @
1994 -1995 Research Scientist @
Catherine Pedersen Education
University of Pennsylvania - The Wharton School
Certificate of Executive Business Management (Organizational Leadership)
2012-2014
Copenhagen University 1992
Charles University in Prague
Master of Science (MgRN - Magister Rerum Naturalium) (Biology, Microbiology)
1984-1991
Catherine Pedersen Skills
Regulatory Affairs
GMP
Quality Assurance
Pharmaceutical Industry
Validation
GxP
Sop
Change Control
Biopharmaceuticals
FDA
Microbiology
Diabetes
cGMP
Process Validation
Pharmaceuticals
CAPA
Biotechnology
21 CFR Part 11
Quality Systems
Quality Management
Clinical Development
GCP
Drug Development
Regulatory Requirements
Clinical Trials
Quality System
Regulatory Submissions
Computer System Validation
Process Optimization
Biochemistry
Molecular Biology
Fermentation
Continuous Improvement
Technology Transfer
Lean Manufacturing
Cleaning Validation
Compliance
Auditing
Aseptic Processing
BPF
Management
Deviation Management
Inspection
Product Release
Quality Control
Standard Operating Procedure (SOP)
U.S. Title 21 CFR Part 11 Regulation
U.S. Food and Drug Administration (FDA)
u.s. Food and Drug Administration Fda
Process Improvement
Standard Operating Procedure Sop
Data Analysis
Strategy
Good Laboratory Practice Glp
Computer System
Standard Operating Procedure
u.s. Food and Drug Administration
Good Laboratory Practice
Catherine Pedersen Summary
Catherine Pedersen, based in California, United States, is currently a VP, Quality Assurance • Healthcare Compliance Head of Quality at Exelixis. Catherine Pedersen brings experience from previous roles at Exelixis, Dynavax Technologies, Novo Nordisk Inc. and Novo Nordisk A/S. Catherine Pedersen holds a 2012 - 2014 Certificate of Executive Business Management in Organizational Leadership @ University of Pennsylvania - The Wharton School. With a robust skill set that includes Regulatory Affairs, GMP, Quality Assurance, Pharmaceutical Industry, Validation and more. Catherine Pedersen has 2 emails and 2 mobile phone numbers on RocketReach.
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