Unifers.ai

L. Scott Mar

Executive Director, Quality @Biomea Fusion

Los Angeles, CA, US
EMAILS
[email protected]
MOBILE NUMBERS
+18•••••••57

Signup · Get unlimited contacts

WORK HISTORY

Apr 2022 — Present

Executive Director, Quality @Biomea Fusion

View department →

San Francisco, CA, US

Responsible 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.

EDUCATION

1996

USC Marshall School of Business

Master of Business Administration - MBA

1991

California State Polytechnic University-Pomona

Bachelor of Science - BS, Computer Information Systems

SKILLS

Business AnalysisFdaQuality AssuranceValidationLaboratory MedicineProcess Improvement21 Cfr Part 11BiotechnologyPharmaceutical IndustryAnalysisGlpCross-Functional Team LeadershipClinical TrialsProject ManagementComputer System ValidationPmpChange ControlBusiness DevelopmentSdlcData SecurityClinical DevelopmentIT StrategyGcpLifesciencesGxpLimsU.s. Title 21 Cfr Part 11 RegulationBusiness ProcessU.s. Food and Drug Administration (Fda)Good Clinical Practice (Gcp)Business Process ImprovementHippaData IntegrityData PrivacyGxp Quality AssuranceClinical QAInformation Technology (IT) AuditRisk Managment and GovernanceCorrective and Preventive Action (Capa)Data Analysis and Reporting

ABOUT L. SCOTT MAR

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)

This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.