Zonia Rueda, DHSc, MBS

Data Integrity and Quality Professional

Data Integrity and Quality professional with expertise in ensuring cGMP compliance, ALCOA+ principles, and laboratory data lifecycle management. Experienced in leading data integrity strategies, conducting risk assessments, and driving continuous improvement across cross-functional teams.

Act as a subject matter expert in data integrity, supporting system upgrades, validation activities (IQ/OQ/PQ), and compliance with global quality standards and regulatory requirements (e.g., 21 CFR Part 11, GAMP 5). Proven ability to maintain data integrity across sites, support audits and inspections, and implement effective data governance practices.

Strong collaborator who partners with Quality, IT, and global teams to enhance laboratory systems, improve processes, and uphold a culture of compliance, safety, and operational excellence.