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Mirna Dipano Location
Seattle, WA, US
Mirna Dipano Work
2019 -now Vice President Quality Assurance and Regulatory Affairs @
2019 -now Vice President Quality and Regulatory @
2016 -now Regulatory Affairs Global Head @ Abbott Hematology
2012 -now Global Program Dignostic Director, Regulatory Affairs @ Novartis Companion Diagnostics
2010 -2012 Director Quality and Regulatory @
2008 -2010 Global Regulatory Affairs Manager @
2006 -2008 Regulatory Affairs Manager @
2004 -2006 Quality Assurance Manager @
1989 -2004 Document Management Group @ Ortho Clinical Diagnostics
1989 -2004 Sr Technical Writer @ Johnson & Johnson
Mirna Dipano Education
Villanova University
Six Sigma Black Belt (Process Excellence)
2006-2007
Regis University
MBA
2003-2005
Kean University
Bachelors of Science (Medical Technology)
1980-1985
Mirna Dipano Skills
Quality System
FDA
Document Management
Quality Assurance
21 CFR Part 11
CAPA
ISO 13485
Regulatory Affairs
Biotechnology
Medical Devices
GMP
Validation
V&V
GLP
ISO
Manufacturing
Quality Management
Cross-functional Team Leadership
Regulatory Submissions
Design Control
Pharmaceutical Industry
Lifesciences
Quality Auditing
Sop
Change Control
Software Documentation
Life Sciences
U.S. Title 21 CFR Part 11 Regulation
Verification and Validation (V&V)
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
Cross Functional Team
Verification and Validation V&V
Corrective and Preventive Action Capa
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation
Mirna Dipano Summary
Mirna Dipano, based in Seattle, WA, US, is currently a Vice President Quality Assurance and Regulatory Affairs at NanoString Technologies, Inc.. Mirna Dipano brings experience from previous roles at NanoString Technologies, Inc., Abbott Hematology, Novartis Companion Diagnostics and Omron Healthcare, Inc.. Mirna Dipano holds a 2006 - 2007 Six Sigma Black Belt in Process Excellence @ Villanova University. With a robust skill set that includes Quality System, FDA, Document Management, Quality Assurance, 21 CFR Part 11 and more. Mirna Dipano has 3 emails and 2 mobile phone numbers on RocketReach.
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