QUALITY ASSURANCE, BUSINESS PLANNING & ANALYSIS, AND PROJECT MANAGEMENT Susan Smith

PERSONAL PROFILE

  • 18 years in pharmaceutical quality systems, technical writing, metrics, and project management.

EXPERTISE

ICH/GCP and GMP, Quality Systems (Document Management/Training), Project Coordination and Management, Costs and Operational Efficiencies, Organizational Data Analysis, Strategic Mapping, Training, eTMF Inspection Preparedness, Budgeting and Headcount Analysis, Metrics and Goals Reporting, Continuous Improvement, SOP Development, Process Mapping, Internal Auditing for Training, and Technical Writing. Special expertise: SharePoint, Veeva, and Trackwise.

PROFESSIONAL EXPERIENCE

Consultant

2017 – Present  Tesaro, Waltham, MA

2017 – 2017   Aegerion, Cambridge, MA

2016 – 2017  Seres, Cambridge, MA

2016 – 2016  Keryx, Boston, MA

2013 – 2016  Agios, Cambridge, MA

2013 – 2013  Alnylam, Cambridge, MA

2011 – 2012  Biogen, Cambridge, MA

2011 – Present  MG Quality Microbiology, LLC

1999 – 2011    Pfizer (Wyeth Biotech), Quality Business Planning Manager

Business Planning Activities

Managed Quality Agreement program for the Andover Site (including co-testing/co-manufacturing agreements). Managed annual operating ($52MM) and capital ($120MM) budgets. Coordinated salary planning activities. Assisted in the development of KPIs and reporting. Supported the development of goals and objectives for site and quality. Participated in weekly site leadership meetings and Lean Six Sigma training/activities. Collaborated with Facilities regarding space planning.

Project Management Activities

Led global team in a project to deliver headcount and organizational data analysis. Identified and implemented a continuous improvement project to streamline and utilize electronic workflows. Headed global team to gain alignment on quality agreement program and strategy. Collaborated on development of project portfolio management program. Created five-year strategic map. Developed and maintained SharePoint site(s) for quality unit and trained administrative staff on maintenance. Developed and managed quality archive. Created TMF indices/files for four clinical studies. Assisted in post- close-out management of eTMF for three studies. Supported implementation of EDMS.

 

 

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