IT Compliance Manager
Managed compliance to regulatory requirements of a highly complex portfolio of 100+ IT systems used in support of company's QMS, including validation, document management and change control
- Trained and coached over 200 employees in different countries on CSV and change management on best practices, regulatory requirements and delivery
- Authored several controlled procedures, quality manuals and local standards aligned to regulatory requirements of GxP IT operations
- Designed a CAPA action plan that lead to stronger contractor delivery and protected record integrity.
- Developed a training plan for the compliance team, which established a novel model to be followed by other business units
- Supported over 15 local and international operations on regulatory inspections and CSV issues resolution
- Achieved Green Belt certification by improving an accounts receivable process that enabled a business region to reduce cash collection time by 30 %