Vicky Rawlinson, PMP, LSSGB

Experience

• 

  Liberty Mutual Insurance

  Jan 1981 - Jan 1984

  Lead Senior IT Programmer

  Comprehensive programming and systems analyst management for corporate customer interactive applications.

• 

  Johnson & Johnson

  Jan 1984 - Jan 1994

  IT Project Manager/Senior Systems Analyst – Manufacturing/Finance

  Oversaw IS manufacturing staff across 5 facilities, providing complete software lifecycle and M&A management.

• 

  Biogen Idec

  Jan 1995 - Jan 2011

  Designed, hired and directed new global R&D quality system function for GCP, GLP and Pharmacovigilance. Oversaw building and implementation across R&D of procedural documentation management, training management, deviation management, CAPA management processes as well as R&D agency inspection and audit response and/or EIR mechanisms. • Designed global resource submission project planning and reporting systems, defining CEO/COO milestone achievement reporting for all submissions relating to the commercial and clinical pipeline for on target agency delivery.• Introduced compliance manager and budget manager roles into Regulatory needed in R&D and or Regulatory and performed roles until approval in 2010. IT business partner for Manufacturing. Accountable for all IT manufacturing staff across three international sites, managing systems life cycle, validation and project management for all IT-related capabilities needed to support the Manufacturing division.

  • Associate Director, R&D Compliance Systems

    Jan 2005 - Jan 2011

  • Manager, R&D Compliance/Project Management

    Jan 2002 - Jan 2005

  • Manager, IT Manufacturing and Business Process Management

    Jan 1995 - Jan 2002
• 

  Various Consultancies

  Feb 2012 - Nov 2014

  Quality and IT Consultant

  Providing Quality Assurance and IT consulting services for biopharmaceutical and medical device companies including:• Oversight, development and conduct of validation programs and activities• Leading software vendor audits • Project management, relationship and compliance manager for implementation of GxP quality systems, pharmacovigilance, clinical, regulatory and technical operations business operations and software