Alma Patricia Bautista

About Alma Patricia Bautista

Promote GMP compliance and provide leadership direction in support of government regulations, corporate, division and site policies, processes, and procedures by adopting a cohesive approach promoting achievements through a collaborative environment. • Project lead for the Compliance Lifecycle and Strategic Readiness implementing harmonized readiness approach across the division to ensure continued cGMP compliance and facility readiness for both internal and external audits.• Established for Core Diagnostics businesses, the ICHAD Inspection Readiness Community of Practice in 2020 to further promote GMP compliance across the ICHAD facilities. • Assessed ADD Lake County Site’s Quality System against the MDSAP (Medical Device Single Audit Program) requirements, ISO 9001:2015 and ISO13485:2016 to identify any gaps prior to certification audit. No gaps were identified, and procedures were prepared during the audit to confirm all MDSAP and ISO requirements are met. ADD Lake County Site received certification for MDSAP and ISO standards with zero nonconformities identified in November 2017.• Assisted with the kick-off of the Global Inspection Readiness Program for new CBER Licensed Product Launched on site in Wiesbaden, Germany and provided guidance to address gaps, risks and actions required to ensure facility was GMP compliant.Quality Management System (QMS) Lead for the implementation of the new European In Vitro Diagnostics Regulation (IVD-R) 2017/746 into Abbott Diagnostics Quality System. Developed with cross-functional team the Person Responsible for Regulatory Compliance (PRRC) process.Quality System Process Owner of the Nonconformance and CAPA Process. Implemented improvements to strengthen the processes to ensure harmonized approach across the division and new metrics to monitor the health of the processes. Additionally, Process Owner alternate for PRRC and QMS Monitoring and responsible maintaining the processes including the Global Quality System Manual. Represent Abbott Laboratories as the DEA (Drug Enforcement Administration) Power of Attorney for the Abbott Park Facility DEA Registrations. As a Corporate policy document owner, responsible for reviewing U.S. DEA 21CFR1300-End regulation changes and federal registrar notices for controlled substances to determine impact to Abbott DEA policies, procedures and training to ensure updates are processed accordingly to align Abbott with the regulation changes or federal registrar notices.

Experience

1. Senior Manager, Quality System and Quality Assurance

   Flex

   Jun 2025 — Present · Austin, TX, US

Education

• Saint Xavier University

  Bachelor of Science - BS, Biology, General

Skills

• Iso 14971
• Iso 13485
• Quality System
• V&V
• U.s. Food and Drug Administration (Fda)
• Glp
• Quality Assurance
• Fda
• 21 Cfr
• Gmp
• Validation
• 21 Cfr Part 11
• Corrective and Preventive Action (Capa)
• Ce Marking
• Design Control
• Gxp
• Quality Auditing
• Change Control
• Medical Devices
• Capa