2016 -2017 Global Lead, Edge Project Business Team @
2011 -2016 Site Head, Quality Operations @
2010 -2011 Senior Director, Quality Systems and Compliance @
2009 -2010 Global Director, Quality Management @
2006 -2008 Director of Validation @
2004 -2006 Associate Director, Validation @
1999 -2004 Director, Validation and Technology Management @
1996 -1999 Validation Engineer @
1993 -1996 Validation @
1991 -1993 Development Section Leader @ CCL
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 3 emails and 2 mobile phone numbers on RocketReach.
Looking for a different Mark Roache?
Find contact details for 700 million professionals.