Vice President, Quality @ (August 2018 - January 2019)
Executive Director, Quality @ (May 2017 - July 2018)
Global Lead, Edge Project Business Team @ (February 2016 - May 2017)
Site Head, Quality Operations @ (September 2011 - January 2016)
Senior Director, Quality Systems and Compliance @ (May 2010 - August 2011)
Global Director, Quality Management @ (January 2009 - May 2010)
Director of Validation @ (January 2006 - December 2008)
Associate Director, Validation @ (January 2004 - January 2006)
Director, Validation and Technology Management @ (January 1999 - January 2004)
Validation Engineer @ (January 1996 - January 1999)
Validation @ (January 1993 - January 1996)
Development Section Leader @ CCL (January 1991 - January 1993)
Mark Roache Education
University of Leicester
Master Of Science
1991-1991
University of Liverpool
Bachelor Of Science (Pharmacology)
1987-1990
Mark Roache Skills
Organizational Development
Organizational Leadership
Change Management
21 CFR
Biotechnology
Validation
GMP
Quality Management
Sop
CAPA
21 CFR Part 11
Quality Assurance
Technology Transfer
FDA
Pharmaceutical Industry
Quality System
Regulatory Affairs
GLP
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
Standard Operating Procedure (SOP)
Change Control
U.S. Title 21 CFR Part 11 Regulation
Biopharmaceuticals
Verification and Validation (V&V)
GxP
Life Sciences
Vaccines
Cross-functional Team Leadership
Pharmaceutical Manufacturing
ERP Implementations
Verification And Validation V&V
Corrective And Preventive Action Capa
Operations
Cross Functional Team Leadership
U.S. Food And Drug Administration Fda
Standard Operating Procedure Sop
Quality Systems
Standard Operating Procedure
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation
Mark Roache Summary
Mark Roache, based in Cary, NC, US, is currently a VP, Cell and Gene Therapies at Quality Executive Partners, Inc. (QxP). Mark Roache brings experience from previous roles at Kbi Biopharma, Avexis, Inc. and Merck. Mark Roache holds a 1991 - 1991 Master Of Science @ University of Leicester. With a robust skill set that includes Organizational Development, Organizational Leadership, Change Management, 21 CFR, Biotechnology and more. Mark Roache has 4 emails and 2 mobile phone numbers on RocketReach.
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