Chief Technology Officer @ (February 2020 - June 2021)
Sr. Vice President Quality and Compliance @ (May 2018 - September 2018)
Director Quality Assurance @ (January 2018 - May 2018)
Vice President @ DRS Services USA (April 2017 - December 2017)
Site Head, Commercial Manufacturing @ (March 2016 - April 2017)
Site Quality Head @ (January 2009 - March 2016)
Director, Quality and Regulatory Compliance @ (August 2006 - December 2008)
Director, Quality and Regulatory @ Mayne Pharma (June 2005 - August 2006)
Site Quality Manager @ (January 2003 - January 2005)
Quality Assurance Manager @ (January 1997 - January 2003)
Supervisor Microbiology @ Magellan Laboratories, Inc. (January 1994 - January 1997)
Assistant Scientist @ Glaxo (January 1990 - January 1994)
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 1 emails and 1 mobile phone numbers on RocketReach.
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