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Quality Management Professional with hands-on experience in research and development organizations. A proven leader with strong advocate for training and compliance; an accomplished manager of technical resources with proven records in building Quality Control programs and motivating successful Quality Assurance efforts. A contributor to the development of departmental business and technical strategies, goals, objectives and related metrics; a skilled developer and keeper of partnerships with cross functional managements, direct reports, peers, service providers, suppliers and other stakeholders.Specialties: QMS & Compliance
Cerevast Medical Inc.
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Vice President, Regulatory & Quality AffairsCerevast Medical Inc. Aug 2015 - PresentDevelop and maintain corporate quality vision, mission, strategic international regulatory plans. Serve as management representative and maintain ISO Certifications.
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Vice President, QualityCerevast Therapeutics, Inc. Dec 2010 - Jul 2015Responsible for the implementation and the maintenance of corporate quality vision, mission, QA strategic plans, and all quality activities related to product development, manufacturing, and post-market surveillance, etc. Designed and validated a quality management system that earned the company's first ISO certification (ISO 13485:2003). Led and coordinated cross-functional efforts to achieve lead product's CE certification.
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Director, Cm&C And Quality AssuranceCerevast Therapeutics, Inc. Jan 2010 - Dec 2010Direct technology transfer of perfluorocarbon containing micropheres drug product. Establish internal quality system to support both drug product and medical device development programs. Setup quality control laboratory to support drug product stability programs.
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Cmc ConsultantIndependent Consulting Oct 2008 - Dec 2009CMC consultant for 5 biotechnology and pharmaceutical firms with phase II and phase III clinical development programs. Developed recommendations and implemented the recommended steps to re-initiate former late phase clinical program. Reviewed and updated Quality Systems for Device and Drug combination firms.
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Senior Director, Quality & Laboratory OperationsOncogenex Pharmaceuticals, Inc. Jan 2007 - Sep 2008• Established and maintained compliant GMP systems with flexibility to support development and operational needs for clinical research IDPs.• Provided inputs to management on the development of departmental business and technical strategies, goals, objectives and related metrics. Deployed strategic goals and objectives through operational plans.• Organized and implemented supply management for clinical research programs.• Managed quality control activities for preclinical and clinical products. Provided leadership to the development and implementation of methods, validations, specifications, and standard operating procedures. Investigated discrepancies, aberrant, OOT, or OOS results, and mitigate unplanned deviations.• Directed vendor selection process, and oversee the evaluation, qualification and re-qualification processes. Developed and maintained business relations with contract manufacturers and service providers.• Facilitated the development of direct reports.
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Director, Quality Control & Lab OperationsSonus Pharmaceuticals 2004 - 2007Us -
Associate Director, Qc & AnalyticalSonus Pharmaceuticals 2002 - 2004Us
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Manager, Qc & AnalyticalSonus Pharmaceuticals 1997 - 2002Us
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Supervisor, Quality ControlSonus Pharmaceuticals 1994 - 1997Us
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ChemistProcyte 1994 - 1994
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Technical Research SpecialistBrigham And Women'S Hospital 1992 - 1994Us
Andrew Leo Skills
Andrew Leo Education Details
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University Of WashingtonChemistry -
University Of PhoenixBusiness
Frequently Asked Questions about Andrew Leo
What company does Andrew Leo work for?
Andrew Leo works for Cerevast Medical Inc.
What is Andrew Leo's role at the current company?
Andrew Leo's current role is Vice President, Regulatory and Quality Affairs at Cerevast Medical Inc..
What is Andrew Leo's email address?
Andrew Leo's email address is al****@****msn.com
What is Andrew Leo's direct phone number?
Andrew Leo's direct phone number is +142582*****
What schools did Andrew Leo attend?
Andrew Leo attended University Of Washington, University Of Phoenix.
What are some of Andrew Leo's interests?
Andrew Leo has interest in Music, Travel, Aviation.
What skills is Andrew Leo known for?
Andrew Leo has skills like Quality System, Biotechnology, Quality Assurance, Validation, Cross Functional Team Leadership, Pharmaceutical Industry, Medical Devices.
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