Amy Markey Email & Phone Number
Vice President, Quality and Compliance @ Cabaletta Bio
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Amy Markey Location
- Philadelphia, PA, US
Amy Markey Work
- 2020 - now Vice President, Quality and Compliance @
- 2019 - 2022 QA Consultant and Sr. Director @
- 2018 - 2021 Executive Board Treasurer @
- 2018 - 2019 Senior Director, GMP Quality Assurance @
- 2016 - 2018 Director, CMC QA and Compliance @
- 2014 - 2016 Quality Assurance Lead @
- 2011 - 2014 VP Quality Assurance @ Nuron Biotech Inc
- 2005 - 2010 Director, Quality Assurance @ Tengion
- 2002 - 2005 Project Manager @
- 2000 - 2002 Regulatory Operations Manager @
- 1998 - 2000 Validation Scientist @
- 1996 - 1998 Microbiology Tech Support Supervisor @
- 1992 - 1996 Validation Project Manager @ Raytheon Engineers & Constructors
Amy Markey Education
- Immaculata University
BA (Biology)
1987 - 1991
Amy Markey Skills
- Chemistry, Manufacturing, and Controls (CMC)
- Validation
- Quality Assurance
- Microbiology
- GMP
- CAPA
- FDA
- Sop
- Biotechnology
- Change Control
- 21 CFR Part 11
- Biopharmaceuticals
- Technology Transfer
- Computer System Validation
- Regulatory Submissions
- Clinical Development
- Quality System
- GxP
- Aseptic Processing
- Quality Auditing
- EDC
- Regulatory Affairs
- IND
- V&V
- Vaccines
- LIMS
- GCP
- Cleaning Validation
- Standard Operating Procedure (SOP)
- U.S. Food and Drug Administration (FDA)
- Verification and Validation (V&V)
- Corrective and Preventive Action (CAPA)
- u.s. Food and Drug Administration Fda
- Corrective and Preventive Action Capa
- Verification and Validation V&V
- Pharmaceutical Industry
- Project Management
- Engineers
- Standard Operating Procedure Sop
- Strategy
- Standard Operating Procedure
- u.s. Food and Drug Administration
- Verification and Validation
- Corrective and Preventive Action
Amy Markey Summary
- Amy Markey, based in Philadelphia, PA, US, is currently a Vice President, Quality and Compliance at Cabaletta Bio. Amy Markey brings experience from previous roles at Carisma Therapeutics, ISPE Delaware Valley Chapter (ISPE DVC), Venatorx Pharmaceuticals, Inc. and Adaptimmune. Amy Markey holds a 1987 - 1991 BA in Biology @ Immaculata University. With a robust skill set that includes Chemistry, Manufacturing, and Controls (CMC), Validation, Quality Assurance, Microbiology, GMP and more. Amy Markey has 3 emails and 2 mobile phone numbers on RocketReach.
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Top Cabaletta Bio Employees
Michael Gerard
General Counsel
United States
Lisa Massmanian
Vice President and Head of Clinical Operations
Waltham, MA, US
Heather Harte-Hall
Chief Compliance Officer
Gladwyne, PA, US
Steve Gavel
Chief Commercial Officer
Philadelphia, PA, US
Amy Markey
Vice President, Quality and Compliance
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Samik Basu
Chief Scientific Officer
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Raj Tummala
Senior Vice President - Clinical Development
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Marcia Gaido
Senior Vice President, Regulatory Affairs
Chapel Hill, NC, US
Neal van Hoeven
Vice President, Preclinical Research
Seattle, WA, US
Kurtis Carlisle
Vice President Supply Chain
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Sarah Yuan
Chief Technology Officer
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Anup Marda
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Jenell Volkov
Vice President, Translational Medicine
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Arun Das
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Houman Dehghani
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Gwendolyn Binder
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