Julie-Susan Harrison

About Julie-Susan Harrison

Pharm /biopharma /medical device professional in Quality Assurance, Validation, Engineering/Manufacturing, Continuous Improvement, QSR and Medical Devices. Strong FDA,EMEA experience. SME in Quality/Compliance, Manufacturing, Material Qualification, Extractable-Leachable programs, Process Validation (Cleaning, Shipping, Manufacturing).Articulate team player with adept risk assessment capabilities. Experience with small molecule, biologics, vaccines, mammalian cell culture, bacterial fermentation, API’s. Extensive experience/proven success in Consent Decree settings, Interim Controls, Batch Record Remediation, Investigations / CAPA, Work Plan execution and Verification activities.Enthusiastically bringing products to market, BIMO SME, serialization and DTP sample programs, complaints, eBR, Change Control, Batch Record Review, Lot Release, CoA and Specification generation.Cell culture/bioreactor/roller bottle operations, Aseptic fill/finish, Lyophilization, API/Bulk protein purification, formulation; Chromatography processes, Microbiological, Environmental ControlsValidation of critical process, equipment, systems, Excellent proven project management, investigation, inspection presentation skills with strong leadership and technical expertise. Incisive investigation and auditing capabilities combined with consistent closure skills. Well versed in ICH guidelines. Proven ability to design and implement Quality concepts and controls into GMP manufacturing as well as the GCP and GLP research environments. Develop, manage and direct cGMP, GPV and GLP Compliance and Quality programs. Experience includes strategic development, maintenance of internal cGMP and Quality policies and procedures, assuring compliance through strong, effective oral and written skills.Extensive experience in Class 100 aseptic processing environments. Background includes vaccines, bulk pharmaceuticals, medical device, clinical trial materials, contract manufacturing. QA, cGMP audits, packaging, manufacturing campaign oversight.

Experience

1. Vice President Quality Assurance

   MapLight Therapeutics, Inc.

   Mar 2023 — Present

Education

• North Shore Community College

  Associate's degree, Management, Restaurant and Culinary Arts

• Northeastern University

  Biotechnology, Continuing Education

• Salem State University

  Biology

• North Shore Community College

  Associate's degree, Biotechnology

• Quinnipiac University

  Bachelor of Science - BS, Health Sciences

Skills

• Glp
• Verification and Validation (V&V)
• Rare Diseases
• Medical Devices
• Capa
• Regulatory Requirements
• Auditing
• Livelink
• Compliance Management
• Batch Release
• Tech Transfer
• Leadership
• Six Sigma Green Belt Certified
• Pharmaceutical Industry
• Sop
• Fda
• Validation
• Regulatory Affairs
• Public Speaking
• Management
• Failure Mode and Effects Analysis (Fmea)
• Laboratory Information Management System (Lims)
• Quality System
• Commisioning and Qualification
• Project Management
• Biopharmaceuticals
• Orphan Drugs
• Root Cause Analysis
• Biotechnology
• Six Sigma
• Gxp
• Quality Auditing
• Aseptic Processing
• Product Specification
• Batch Records
• Deviations
• Change Control
• CRO Management
• Good Clinical Practice (Gcp)
• Cap/Clia