Systems and Process Manager in Cell and Gene Therapy @ (April 2020 - July 2021)
Sr. Contract Manager @ GlaxoSmithKline (January 2018 - April 2020)
Regulatory Compliance Manager @ GalxoSmithKiline (January 2015 - January 2018)
Regulatory Project Manager @ (February 2013 - January 2015)
Senior Advisor, BQA @ (October 2011 - February 2013)
QA Specialist @ (June 2004 - October 2011)
Manufacturing Operations Specialist @ (May 2001 - June 2004)
Research Tech. @ (May 2000 - June 2001)
Bree C Education
Temple University
Certificate (QA/RA)
2004-2006
University of the Sciences in Philadelphia
Microbiology (General)
1996-2000
Bree C Skills
21 CFR Part 11
Batch Records
Batch Release
Biochemistry
Biopharmaceuticals
CAPA
Cell Culture
Cell and Gene Therapy
Change Control
Clinical Development
Clinical Trials
Communication
Complaint Investigations
Contractual Obligations
Corrective Actions
Deviations
EMA
FDA GMP
Gene Therapy
Good Manufacturing Practice (GMP)
GxP
International New Drug Applications
Mobile Banking
Quality Assurance
Quality Auditing
Quality Management
Quality System
R&D
Regulatory Affairs
Regulatory Inspections
Regulatory Submissions
Risk Assessment
Risk Management
Software Documentation
Strategic Thinking
Technical Writing
Third Party Inspection
V&V
Validation
Written Communication
Bree C Summary
Bree C, based in Riverside, NJ, US, is currently a Product Quality Strategy Lead, Director of Product Quality at GSK. Bree C brings experience from previous roles at GlaxoSmithKline, GSK and GalxoSmithKiline. Bree C holds a 2004 - 2006 Certificate in QA/RA @ Temple University. With a robust skill set that includes 21 CFR Part 11, Batch Records, Batch Release, Biochemistry, Biopharmaceuticals and more. Bree C has 2 emails and 1 mobile phone numbers on RocketReach.
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