Gwendolyn Fisher

Accomplishments

• Designed, validated, and implemented global QMS to support business within nine months
• Developed QMS leaders to support global QMS and promoted to management level

Responsibilities

• Provide leadership and direction through quality managers with total department of 35+ employees
• Responsible for complaints, medical device reporting, CAPA, nonconformance, field action/recall, change control, document control, management review, training, GxP IT system validations
• Execute business plans and contribute to the development of global quality strategies
• Decisions guided by functional or major operational strategy and priorities
• Drive continuous improvements and streamlining of global QMS
• Head Risk Management Board and Data Review Board
• Lead on-site regulatory inspections and audits

Accomplishments

• Implemented process improvement for in-country relabeling requirements to sustain compliance
• Enhanced risk management reporting to improve timelines and reporting
• Qualified China distribution center to perform relabeling and repackaging activities

Responsibilities

• Managed four life cycle quality engineers for capital equipment
• Led continuous product quality improvements to support product lifecycle
• Headed Risk Management Board and Data Review Board
• Maintained product risk management files and reporting per ISO 14971

Accomplishments

• Improved audit timeliness metrics from 90% within one year
• Hosted successful corporate audits, FDA inspections, and ISO 13485 audits

Responsibilities

• Headed site inspection readiness program for three medical device manufacturing sites
• Led inspection back rooms, composed responses to findings, and tracked completion of actions
• Maintained internal audit program including multi-site audit schedules and audit plans/reports

• Reduced stability reporting backlog based on project plan and maintained zero backlog
• Implemented stability process improvements for increased cGMP compliance and efficiencies
• Reduced cost for instrument qualification and improved utilization of resources
• Responsibilities
• Managed team of three - stability analyst, technical writer, and chemist
• Administered ancillary laboratory systems and stability program

• Assisted Quality Director to develop new department and implement supplier quality processes
• Managed international external pharmaceutical manufacturers (aseptic and sterile manufacturing)
• Released pharmaceutical products for US market via review/approval of batch records
• Composed, negotiated, and maintained quality agreements with external manufacturers
• Conducted due diligence cGMP compliance audits of external manufacturers

• Regulatory Compliance Supervisor
• Regulatory Compliance Auditor (auditor of API, components, finished product)
• Quality Control Chemist