L. Scott Mar, Mba Email and Phone Number
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* 18+ years GCP/GLP audit and compliance experience. 22+ years in the Biopharma industry.* 19+ years experience managing large and small teams* Exposure to GCP medical device studies* Experienced in hosting US FDA, China FDA, MHRA and EMA regulatory inspections* Solid understanding of audits of Bioanalytical Pipelines and the application of Artificial Intelligence (AI) classifiers* Subject matter expert in Data Integrity, Computer System Validation (CSV) and 21 CFR Part 11 Compliance* Subject matter expert in all Clinical and Preclinical technologies (i.e. EDC, IVR/IWR, Imaging, ePRO, LIMS)
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Executive Director, QualityBiomea FusionLos Angeles, Ca, Us
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Executive Director, QualityBiomea Fusion Apr 2022 - PresentDowntown Redwood City, California, UsResponsible for all GxP audit and compliance programs, including training and document control activities. Provide prospective compliance advice to clinical study teams, organize and execute vendor and clinical site audits. Develop Biomea QMS. Coordinate and conduct inspection readiness activities. -
Senior Director R&D Quality AssuranceSummit Therapeutics Oct 2021 - Apr 2022Miami, Florida, UsLed R&D Quality Assurance group, with broad oversight over GCP, GLP, PV and Computer System Validation (CSV) activities. Provided leadership in providing prospective compliance advice, overseeing audit program and directing inspection preparation/readiness activities. -
Director Clinical ComplianceGrail, Inc. Sep 2020 - Oct 2021Menlo Park, Ca, UsProvided Clinical Compliance leadership in oversight of vendor and clinical site audits, in addition to providing prospective compliance advice to clinical study teams. Provided compliance oversight of Computer System Validation (CSV) of clinical systems, including EDC, CTMS and eTMF. Managed CAPA process for clinical trials and related remediations. Led inspection preparation activities. -
Associate Director, Clinical Quality AssuranceAbbvie May 2017 - Sep 2020North Chicago, Illinois, UsProvided oversight, and management of GCP/GLP audits of clinical sites, vendors and internal processes. Hosted GCP regulatory inspections, and led inspection prep/readiness activities. Provided proactive GCP compliance advice to clinical study teams. Headed Computer System Validation (CSV) related quality assurance activities in the R&D space. Supervised, mentored and trained junior staff auditors. -
Senior Manager, Clinical Quality AssuranceAmgen Apr 2006 - May 2017Thousand Oaks, Ca, UsManaged team of senior-level auditors in planning and conducting investigator site, service provider, and internal process audits for clinical (GCP) and preclinical (GLP) studies. Tracked issues through remediation and closure. Planned annual audit program. Subject matter expert for GxP technologies including EDC, IVR/IWR, Imaging, and Lab technology (analytical instruments). Hosted FDA, EMA, and MHRA regulatory inspections. -
Senior Manager, Information SystemsAmgen Apr 2002 - Apr 2006Thousand Oaks, Ca, UsProvided program oversight for the validation of analytical instruments, LIMs and data management systems for clinical/preclinical GxP labs. Established the analytical instrument systems validation methodology (CSV) for the Amgen GLP labs.
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Managing ConsultantDeloitte May 2000 - Oct 2001Worldwide, OoProvided technology strategy and eCommerce consulting services across industry sectors. -
Managing ConsultantStructure Consulting Dec 1999 - May 2000Provided eCommerce strategy and implementation services.
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Principal Consultant (Manager)Pwc Oct 1997 - Dec 1999GbProvided technology strategy and IT project management services across a broad range of industries, including public utilities, financial services and electronics manufacturing sectors. -
ConsultantAccenture Aug 1996 - Oct 1997Dublin 2, IeProvided IT consulting and information system project management services to public utility clients.
L. Scott Mar, Mba Skills
L. Scott Mar, Mba Education Details
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Usc Marshall School Of BusinessMaster Of Business Administration - Mba -
California State Polytechnic University-PomonaComputer Information Systems
Frequently Asked Questions about L. Scott Mar, Mba
What company does L. Scott Mar, Mba work for?
L. Scott Mar, Mba works for Biomea Fusion
What is L. Scott Mar, Mba's role at the current company?
L. Scott Mar, Mba's current role is Executive Director, Quality.
What is L. Scott Mar, Mba's email address?
L. Scott Mar, Mba's email address is ls****@****hoo.com
What is L. Scott Mar, Mba's direct phone number?
L. Scott Mar, Mba's direct phone number is (805) 447*****
What schools did L. Scott Mar, Mba attend?
L. Scott Mar, Mba attended Usc Marshall School Of Business, California State Polytechnic University-Pomona.
What skills is L. Scott Mar, Mba known for?
L. Scott Mar, Mba has skills like Quality Assurance, Fda, Biotechnology, Validation, Project Management, 21 Cfr Part 11, U.s. Food And Drug Administration, Business Analysis, Cross Functional Team Leadership, Pharmaceutical Industry, Computer System Validation, Sdlc.
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