L. Scott Mar, MBA CISA

Executive Director, Quality at Biomea Fusion
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Contact Information
us****@****om
(386) 825-5501
Location
Los Angeles Metropolitan Area

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Evan Blander

Scott is a very strong and detailed project manager. I was able to give him a project and ensure that it would be completed, on time, within budget, and to the client's (and my own) satisfaction. Additionally, he is very personable and a good communicator.

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Credentials

  • Dare to Lead Trained
    Dare to Lead™ Trained
    Dec, 2019
    - Nov, 2024
  • Certified Information Systems Auditor (CISA)
    ISACA
    Aug, 2008
    - Nov, 2024

Experience

  • Biomea Fusion
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Executive Director, Quality
      • Apr 2022 - Present

      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. 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.

  • Summit Therapeutics, Inc.
    • United States
    • Biotechnology Research
    • 1 - 100 Employee
    • Senior Director R&D Quality Assurance
      • Oct 2021 - Apr 2022

      Led 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. Led 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.

  • GRAIL
    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Director Clinical Compliance
      • Sep 2020 - Oct 2021

      Provided 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. Provided 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.

  • AbbVie
    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Associate Director, Clinical Quality Assurance
      • May 2017 - Sep 2020

      Provided 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. Provided 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.

  • Amgen
    • United States
    • Biotechnology Research
    • 700 & Above Employee
    • Senior Manager, Clinical Quality Assurance
      • Apr 2006 - May 2017

      Managed 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 Systems
      • Apr 2002 - Apr 2006

      Provided 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.

  • Deloitte
    • Business Consulting and Services
    • 700 & Above Employee
    • Managing Consultant
      • Jul 2000 - Oct 2001

      Implemented enterprise-scale eProcurement solutions. Managed and mentored junior consultants. Directed implementation from conception through completion. Implemented enterprise-scale eProcurement solutions. Managed and mentored junior consultants. Directed implementation from conception through completion.

  • Structure Consulting Group
    • Tiburon, CA
    • Managing Consultant
      • Jan 2000 - Jun 2000

      Defined strategic direction for enterprise eProcurement projects, while managing the day-to-day aspects of client relationships. Managed and mentored junior consultants. Defined strategic direction for enterprise eProcurement projects, while managing the day-to-day aspects of client relationships. Managed and mentored junior consultants.

  • PwC
    • Professional Services
    • 700 & Above Employee
    • Principal Consultant
      • Nov 1997 - Jan 2000

      Architected information systems solutions supporting a variety of industries, including semiconductor, public utilities and insurance. Defined strategic-level technology plans, including financial modeling, targeted at executive-level decision makers. Executed systems implementation projects and mentored junior consultants. Architected information systems solutions supporting a variety of industries, including semiconductor, public utilities and insurance. Defined strategic-level technology plans, including financial modeling, targeted at executive-level decision makers. Executed systems implementation projects and mentored junior consultants.

  • Accenture
    • Ireland
    • Business Consulting and Services
    • 700 & Above Employee
    • Consultant
      • Sep 1996 - Nov 1997

      Managed the design and development of electricity generation market simulation models for the public utility industry. Managed the design and development of electricity generation market simulation models for the public utility industry.

  • Southern California Edison (SCE)
    • United States
    • Utilities
    • 700 & Above Employee
    • Systems Analyst
      • Apr 1990 - Mar 1994

      Investigated the application of emerging technologies (artificial intelligence, object oriented systems, etc.) to business problems. Developed training and education courses for the introduction of new technologies within the IT organization. Investigated the application of emerging technologies (artificial intelligence, object oriented systems, etc.) to business problems. Developed training and education courses for the introduction of new technologies within the IT organization.

Education

  • University of Southern California - Marshall School of Business
    Master of Business Administration - MBA
  • California State Polytechnic University-Pomona
    Bachelor of Science - BS, Computer Information Systems

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