2018 -
2018 Sr. Vice President Quality and Compliance @
2018 -
2018 Director Quality Assurance @
2017 -
2017 Vice President @ DRS Services USA
2016 -
2017 Site Head, Commercial Manufacturing @
2009 -
2016 Site Quality Head @
2006 -
2008 Director, Quality and Regulatory Compliance @
2005 -
2006 Director, Quality and Regulatory @ Mayne Pharma
2003 -
2005 Site Quality Manager @
1997 -
2003 Quality Assurance Manager @
1994 -
1997 Supervisor Microbiology @ Magellan Laboratories, Inc.
1990 -
1994 Assistant Scientist @ Glaxo
James Bircher Education
Marshall University Joan C. Edwards School of Medicine
Bachelor of Science (Zoology, Microbiology, and Chemistry)
1986
-
1990
Barrington High School 1984
-
1986
Maumee Valley Country Day School 1982
-
1984
James Bircher Skills
Medical Devices
Regulatory Affairs
FDA
Quality System
Aseptic Processing
Sales
Research
Leadership
Pharmaceutical Industry
CAPA
GMP
Microsoft Excel
ISO 13485
Validation
Management
Quality Assurance
V&V
Computer System Validation
Strategy
Biotechnology
Microsoft Office
Business Development
Verification and Validation V&V
Corrective and Preventive Action Capa
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Verification and Validation
Corrective and Preventive Action
James Bircher Summary
James Bircher, based in Holly Springs, NC, US, is currently a Chief Technical Operations Officer at Spur Therapeutics. James Bircher brings experience from previous roles at Abeona Therapeutics Inc. and DRS Services USA. James Bircher holds a 1986 - 1990 Bachelor of Science in Zoology, Microbiology, and Chemistry @ Marshall University Joan C. Edwards School of Medicine. With a robust skill set that includes Medical Devices, Regulatory Affairs, FDA, Quality System, Aseptic Processing and more. James Bircher has 3 emails and 1 mobile phone numbers on RocketReach.
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