L. Scott Mar
Executive Director, Quality
- Role
- Executive Director, Quality at Biomea Fusion
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
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)
Experience
Executive Director, Quality
Apr 2022 — Present · 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
USC Marshall School of Business
Master of Business Administration - MBA
1996
California State Polytechnic University-Pomona
Bachelor of Science - BS, Computer Information Systems
1991
Skills
- Business Analysis
- Fda
- Quality Assurance
- Validation
- Laboratory Medicine
- Process Improvement
- 21 Cfr Part 11
- Biotechnology
- Pharmaceutical Industry
- Analysis
- Glp
- Cross-Functional Team Leadership
- Clinical Trials
- Project Management
- Computer System Validation
- Pmp
- Change Control
- Business Development
- Sdlc
- Data Security
- Clinical Development
- IT Strategy
- Gcp
- Lifesciences
- Gxp
- Lims
- U.s. Title 21 Cfr Part 11 Regulation
- Business Process
- U.s. Food and Drug Administration (Fda)
- Good Clinical Practice (Gcp)
- Business Process Improvement
- Hippa
- Data Integrity
- Data Privacy
- Gxp Quality Assurance
- Clinical QA
- Information Technology (IT) Audit
- Risk Managment and Governance
- Corrective and Preventive Action (Capa)
- Data Analysis and Reporting
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