Sharon Perry
Vice President, Regulatory Affairs and Quality at ARCA biopharma, Inc.- Claim this Profile
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Bio
Aurora Sosa
Sharon is the QA lead for all projects at ARCA. She managed a team as well as contractors, wrote and reviewed significant QA/QC aspects of sections regarding of IND's, NDA's and their amendments as well as significant sections of other large proposals. Sharon really did an outstanding job keeping great relationships with ARCA contractors but she also knew when to address or bring issues to the team that would impact our products and/or regulatory filings. Sharon also led the effort to bring ARCA up to speed in terms of our SOP's and compliance and as a start up company this always requires a great deal of work and dedication. It was a pleasure to work with Sharon and I appreciated her grounded and practical approach to resolving issues.
Aurora Sosa
Sharon is the QA lead for all projects at ARCA. She managed a team as well as contractors, wrote and reviewed significant QA/QC aspects of sections regarding of IND's, NDA's and their amendments as well as significant sections of other large proposals. Sharon really did an outstanding job keeping great relationships with ARCA contractors but she also knew when to address or bring issues to the team that would impact our products and/or regulatory filings. Sharon also led the effort to bring ARCA up to speed in terms of our SOP's and compliance and as a start up company this always requires a great deal of work and dedication. It was a pleasure to work with Sharon and I appreciated her grounded and practical approach to resolving issues.
Aurora Sosa
Sharon is the QA lead for all projects at ARCA. She managed a team as well as contractors, wrote and reviewed significant QA/QC aspects of sections regarding of IND's, NDA's and their amendments as well as significant sections of other large proposals. Sharon really did an outstanding job keeping great relationships with ARCA contractors but she also knew when to address or bring issues to the team that would impact our products and/or regulatory filings. Sharon also led the effort to bring ARCA up to speed in terms of our SOP's and compliance and as a start up company this always requires a great deal of work and dedication. It was a pleasure to work with Sharon and I appreciated her grounded and practical approach to resolving issues.
Aurora Sosa
Sharon is the QA lead for all projects at ARCA. She managed a team as well as contractors, wrote and reviewed significant QA/QC aspects of sections regarding of IND's, NDA's and their amendments as well as significant sections of other large proposals. Sharon really did an outstanding job keeping great relationships with ARCA contractors but she also knew when to address or bring issues to the team that would impact our products and/or regulatory filings. Sharon also led the effort to bring ARCA up to speed in terms of our SOP's and compliance and as a start up company this always requires a great deal of work and dedication. It was a pleasure to work with Sharon and I appreciated her grounded and practical approach to resolving issues.
Credentials
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RAC
Regulatory Affairs Professionals Society (RAPS)
Experience
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ARCA biopharma, Inc.
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United States
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Biotechnology Research
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1 - 100 Employee
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Vice President, Regulatory Affairs and Quality
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Jul 2020 - Present
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Senior Director Regulatory Affairs & Quality
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Jul 2013 - Jul 2020
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Director Quality Assurance
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Oct 2012 - Jun 2013
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Associate Director Quality
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Jan 2008 - Oct 2012
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QA Manager
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Oct 2007 - Jan 2008
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Gilead Sciences
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United States
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Biotechnology Research
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700 & Above Employee
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Contract- QA Specialist III
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Aug 2007 - Oct 2007
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Parkway Products, LLC
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United States
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Plastics Manufacturing
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100 - 200 Employee
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Contract Quality
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Feb 2007 - Aug 2007
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Chemist
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May 2004 - Apr 2006
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PR Pharmaceuticals
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Manager Quality
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Oct 1998 - Oct 2002
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Pfizer
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Release Coordinator
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Dec 1987 - Jun 1998
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Education
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Avila University
BS, Chemistry, Biology