Executive Director of Quality @ PCI Pharma Services
Director Quality Assurance @ Dohmen Life Science Services
Senior Director Quality Assurance @ Exact Sciences
Education:
BA, Biochemistry @
Boston University
About:
As a seasoned Quality and Regulatory leader, I’ve leveraged 15+ years of experience leading cross-functional teams in a broad set of industries, which range from startup to multi-national Fortune 500 companies.
My experience spans a variety of functions including Quality Assurance, Regulatory Affairs, Manufacturing, Research and Development, Product and Process Engineering, Distribution, Supply Chain, and Program Management.
As a seasoned Quality and Regulatory leader, I’ve leveraged 15+ years of experience leading cross-functional teams in a broad set of industries, which range from startup to multi-national Fortune 500 companies.
My experience spans a variety of functions including Quality Assurance, Regulatory Affairs, Manufacturing, Research and Development, Product and Process Engineering, Distribution, Supply Chain, and Program Management. This background includes strategic planning, compliance, operational excellence and business integration with a focus on reducing complexity in the business environment.
Founder, Principal Consultant @ Regulatory and Quality System consulting services designed to assist with regulatory strategy, Quality System implementation, and guidance on customer relationships with regulatory agencies based on a wealth of past experience. From August 2015 to Present (5 months) Senior Director Quality Assurance @ From June 2012 to June 2015 (3 years 1 month) Design Assurance Manager @ From January 2011 to June 2012 (1 year 6 months) Manager, Reagent Quality Assurance @ From April 2003 to January 2011 (7 years 10 months) Technical Production Scientist @ From October 2001 to April 2003 (1 year 7 months) Research Scientist @ From June 1999 to September 2001 (2 years 4 months) Clinical Research Associate @ From September 1997 to April 1999 (1 year 8 months)
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