Data Governance Manager (Laboratory Operations) & CSV/CSA & Data Integrity

Led computerized systems validation (CSV) aligned with FDA, EMA, and other regulatory quality compliance requirements

Ensured data integrity of information transmitted through computerized systems throughout its lifecycle

Maintained and updated validation documentation and data integrity records for audits and regulatory reviews

Guaranteed compliance with applicable regulatory standards and participated in internal and external audits

Trained laboratory personnel on CSV and data integrity policies and procedures to foster a culture of compliance

Implemented continuous monitoring processes to detect and address data integrity issues in real time

Provided ongoing support and maintenance for system issues

Implemented CSV across laboratories in Mexico, Argentina, and Brazil within three months, meeting FDA, INVIMA, and ANVISA standards on time and within budget

Led SAP QM support governance implementation, ensuring high compliance levels and master data quality consistency for Material Master management

Developed and implemented a comprehensive data integrity program that reduced discrepancies by 25%

Organized communities of practice for continuous review of critical data integrity issues, achieving a 20% reduction in operational risks

Passed regulatory audits from FDA, INVIMA, and ANVISA without critical findings

Introduced automation tools (Power Automate, Alteryx) to optimize validation processes, reducing operational time and costs by 1.5 FTEs

Designed and executed advanced training on SAP, CSV, and data integrity, reducing human errors by 40%

Implemented agile methodologies and digital tools training, enhancing the team’s capacity to lead digital transformation and analytics projects

Designed, implemented, and maintained Quality Management Systems (QMS) under ISO 9001 standards

Led implementation of data integrity systems; mapped processes to identify vulnerabilities and apply controls

Oversaw data integrity in critical systems to ensure accuracy, security, and completeness

Developed solutions to prevent unauthorized access and ensure data traceability

Led digitalization projects to optimize workflows and automate change management and deviation control processes

Coordinated internal and external audits with FDA, COFEPRIS, INVIMA, and ANVISA to achieve outstanding regulatory compliance

Developed training programs on quality management, data integrity, and digitalization

Implemented continuous improvement systems to monitor and optimize QMS and digitalization, reducing costs

Managed and updated quality and digitalization documentation to ensure audit readiness

Led data migration and backup projects resulting in zero failures

Reduced product failures from 60% to 10% through advanced root cause analysis methodologies

Automated key processes including root cause analysis, reducing cycle times by 40% and improving data accuracy by 30%

Implemented data integrity governance, reducing data errors by 50%

Coordinated audits with zero major nonconformities and only one minor observation

Developed comprehensive training programs that increased staff competence by 50%

Introduced quality process improvements that reduced operational costs by 20% and increased customer satisfaction by 15%

Improved plant productivity from 40% to 80% through agile methodology implementation