David Moyer Email and Phone Number
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Client-focused pharmaceutical executive with over 30 years’ experience as a leader in quality system development. Master regulatory compliance problem solver – small and large molecules / early phase through commercial. Extensive experience in supplier selection and approval; coordination of strategic plans to prepare manufacturing sites for critical inspections; and direct interface with FDA, EMA and other regulatory bodies.• GMP oversight of new facility design • Quality management of tech transfer• Onsite contract manufacturing support • Regulatory inspection hosting
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President And CeoLenape Pharma Gmp Consulting, Llc Aug 2016 - PresentRaleigh-Durham, North Carolina AreaHands-on support on matters pertaining to Quality Management Systems and cGMP Regulatory Compliance for Pharmaceutical and Biopharmaceutical companies. Led the start-up of a regulatory compliance consulting firm on a foundation of long-term business associations with an array of pharma companies and professionals covering the full spectrum of pharmaceutical development and commercial manufacturing. Initial client engagements include:• Creation and rollout of a Quality Management System for a virtual company preparing for its first commercial launch.• Remediation of critical supplier manufacturing and control issues identified by a regulatory agency inspector to minimize sponsor company product impact risk.
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Global Compliance Practice LeadIcon Plc May 2014 - Jul 2016Raleigh, Nc -
Vice President, Regulatory ComplianceAptiv Solutions, An Icon Plc Company Jun 2010 - Apr 2014Durham, North Carolina -
Vice President, Regulatory ComplianceFulcrum Pharma Developments, Inc. Sep 2002 - May 2010Morrisville, Nc -
Director Quality AssuranceDiosynth (Formerly Covance Biotechnology Services) Jan 2000 - Aug 2002Research Triangle Park, Nc
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Vp, Compliance ProgramsPhoenix Regulatory Associates Apr 1995 - Jan 2000Sterling, Va
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Director Quality AssuranceSomatogen Apr 1994 - Apr 1995Boulder, Co
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Manager Quality AssuranceGlaxo Inc Mar 1989 - Apr 1994Research Triangle Park, Nc
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Section Head / Department Head ComplianceBurroughs Wellcome Company Mar 1979 - Mar 1989Greenville, Nc
David Moyer Skills
Frequently Asked Questions about David Moyer
What company does David Moyer work for?
David Moyer works for Lenape Pharma Gmp Consulting, Llc
What is David Moyer's role at the current company?
David Moyer's current role is President and CEO at Lenape Pharma GMP Consulting, LLC.
What is David Moyer's email address?
David Moyer's email address is da****@****plc.com
What is David Moyer's direct phone number?
David Moyer's direct phone number is (919)-226*****
What skills is David Moyer known for?
David Moyer has skills like Quality Systems Expert, Cmo Selection And Management, Team Leader Advocate For Continuous Process Improvement, Start Up Specialist, Technology Transfer, Fda Pre Approval Inspection Readiness, Fda Consent Decree Recovery, Fda, Continuous Improvement, Quality System, Quality Assurance, Medical Devices.
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David Moyer
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