Aysegul Balci

• Single point of Quality contact at CMC Matrix teams, governance and other strategic meetings.
• Leaded and managed the delivery of all the quality aspects of the product/project through the development cycle, commercialization and life cycle management.
• Succeeded FDA, PMDA Pre-Approval Inspection at Drug Product and Drug Substance sites with No Observation.
• Approved CMC Quality Modules in clinical & commercial files.
• Leaded and approved responses for Health Authorities questions.
• Developed implementation plans into regulatory filings and coordinate with supply chain for implementation of such changes across all jurisdictions.
• Leaded China Quality compliance working team for New Product Introduction process.

• Leaded Operational and New Product Introduction Quality process at contract manufacturers.
• Provided clearly Quality expectations and defined Quality strategy for product portfolio throughout clinical development, commercialization and lifecycle management activities.
• Delivered cost saving, OE, process improvement & simplification projects.
• Improved Due Diligence Quality & Technical assessment process.

• Accountable for GSK Product Quality Operations at contract manufacturers.
• Delivered E2E product Quality Strategic Plan with clear ownership for each deliver with Supply, Business, MSAT, LOC Quality, Regulatory Leaders.

Leaded Operational Quality activities and site closure quality plan

• Leaded validation activities for app. 400 aseptic, terminal sterile formulations.

• Responsible for Analytical Method Development & Validation
• Analyzed API, excipient, finished product release, stability testing