Summary
Versatile leader with advanced knowledge of Performance Excellence, Quality Assurance, and Compliance. Strong skills in mentoring, staff development and training. Excel in driving successful change efforts with measurable results.
Highlights
Training, Coaching, Mentoring
Budgeting and resource management
Quality Management System
Performance criteria tracking
Change Initiative Leadership
Audit and Audit Defense
Baldrige, ISO, Lean, 6 Sigma
Accomplishments
Leadership
Served as key contributing member to Leadership teams.
Led teams through multiple organizational transitions.
Developed and delivered key training for Compliance Initiatives
People Management
Interviewed, hired, and managed staff performance including performance improvement plans
Financial Management:
Developed and managed cost center operating plan and budget to within 5% of target.
PROFESSIONAL EXPERIENCE
GE Healthcare
Senior Compliance Manager 2006-Present
Operations Manager for IT Compliance Team
Primary IT Representative during FDA and 3rd party audits of CSV
Led the local compliance remediation efforts to validate computer systems under consent decree.
Quality Assurance approver for computer system validations for site under consent decree
Help define QMS and supporting compliance processes, methods, and techniques for computer system validation – Developed Training to take across Company
Team leader within IT QA
Coach global teams in compliance.
Selection of Suppliers of Contractors
Work with external consultant to evaluate current practices with industry best practices
Consulting: ELIASSEN – PFIZER INC., New London, CT 2001 – 2004, 2005
Quality Management Specialist – Pfizer Global Research & Development Informatics
Consult with project teams and provide quality oversight to ensure appropriate life cycle processes and methods are implemented, ensuring efficient and effective project implementation for the development and maintenance of a portfolio of computerized systems used to support clinical trials.
Assess products for compliance with 21 CFR Part 11 as well as GxP
Train project teams on internal software development lifecycle
Mentor new team members
Consulting: QUALIFIED DATA SYSTEMS – CORDIS, INC., Warren, NJ 2004
Project Manager
Managed team of consultants performing validation for laboratory used to support medical device research and development
Maintained project plans, schedules, and staff assignments
Reviewed and approved validation deliverables
Managed client relationship, issue resolution process, status reporting
Early Career
INTEL CORPORATION, UT Senior Quality and Reliability E...
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