Site Head of IT for Houston Manufacturing Plant, responsible for delivering IT services to support Manufacturing, Quality and Supply Chain.Led program to integrate SAP with MES and other shop floor systems. Delivered AI solution to streamline sterilization and QA release process. Collaborated with Analytics and RPA teams to deliver real-time analytics and AI to automate QA data mining, reducing cycle times from 3 days to less than 3 minutes.

Responsible for defining the strategies and management of resources supporting Edwards Digital Roadmap. System Owner of Edwards Enterprise Global Quality Management System (ETQ); Established Project Management Office (PMO) and Quality Data Analytics teams.• Transformed Global Supply Chain & Quality functions through innovation and led the delivery of a global EQMS platform for CAPA, NCR and Supplier Audit.

• Transformed Global Supply Chain & Quality functions through innovation and led the delivery of a global Enterprise Quality Management System (EQMS) for CAPA, NCR and Supplier Audit on the Reliant ETQ platform.

Led a global initiative to deploy an Enterprise Quality Management System (EQMS) for the industry leader in sports medicine and arthroscopic surgical devices. Scope of program included deployment for all US and EU operations, integration with SAP, process harmonization, ensuring compliance with CFR 21 Part 11 and organizational change management.

Directed R&D Business Relationship Management and Project Management activities to define technology roadmaps and align, manage and deliver transformative solutions. Collaborated with Enterprise Architecture and technology support functions to develop and deliver solutions to speed business innovation, increase efficiency and improve compliance. Managed application portfolio with financial responsibility in excess of $10M annually.

Led the R&D IS organization for a $1.2B medical device business. Managed the application portfolio and technology prioritization across multiple US, EU and LatAm locations. Coordinated with Corporate IS for local site operations, and ERP implementation for new business units. Ensured IT strategies aligned with critical business initiatives and core operational processes. Served as IT Lead on several cross-functional initiatives including improving employee engagement and career development. Lead IT integration on M&A and divestiture projects.

Led a team of Global Regulatory Affairs professionals responsible for lifecycle management of approved products, state licensing, and regulatory support for new product registrations and renewals for international affiliates. Implemented process improvement initiatives and a workflow management system to streamline international support processes and reduce international approvals timelines. Maintained compliance with all US state licensing procedures and improved processes to avert registration delays and financial penalties.

Led Global Regulatory and Pharmacovigilance Operations with responsibility for US Regulatory Affairs, Regulatory Publishing, Information Management, Pharmacovigilance Operations, and Quality & Training Effectiveness. Managed a team of Global Regulatory Liaisons responsible for lifecycle management of approved products, state licensing, regulatory support for new product registrations and renewals for international affiliates, business partners and distributors. Expanded Regulatory Publishing service offerings and operational model to provide publishing services for all regulatory submissions globally. Established Global Regulatory Quality, Standards and Training function with responsibility for developing SOPs and training plans, leading internal audits and supporting regulatory inspections worldwide. Directed Pharmacovigilance operations and improved adverse event reporting compliance rates to bring inline with industry standards.

Directed Pharmacovigilance and Safety Information Management operations, as part of Allergan’s overall Regulatory Risk Management and Epidemiology function. Responsible for collection, management and reporting of adverse events for investigational and approved products. Increased adverse event reporting compliance through the implementation of improved standards and procedures. In-sourced external call center operations to save over $500k in annual expenses.

Consolidated US/EU operations and established Global Bioinformatics function, providing centralized safety support for all of Baxter's subsidiaries, and integrated services into global regulatory and vigilance function. Directed global operations and ran technology strategy at multiple sites in EU and US. Consolidated drug safety systems onto single global platform and harmonized processes for streamlined operations. Managed electronic reporting and system improvement projects; deployed signal detection technologies for trend analysis and proactive compliance monitoring. Served as official delegate on project team with US FDA and other industry participants for electronic reporting and was recognized with an award from FDA Commissioner for contributions.

Created Baxter’s EU Safety Systems business unit, and integrated services into Pharmacovigilance function. Supported Pharmacovigilance operations across multiple therapeutic areas and business franchises. Directed software development projects, business intelligence (BI) and user support operations for pharmacovigilance systems including ORACLE AERS, ClinTrace and internally developed systems. Served as company delegate on EudraVigilance Working Group and actively participated in standards development and system initiatives with the EU Medicines Agency (EMA). Provided systems and validation support for regulatory inspections and internal audits.

Project Manager in Baxter’s R&D IT Group, responsible for managing technology projects to transform Regulatory Affairs and Pharmacovigilance operations.

Managed the implementation of Rational's RequisitePro (RP)for requirements management. As RP System Administrator, supported software development projects for Amgen’s enterprise Learning Management System.

Managed the implementation of RequisitePro (RUP) and Rational Unified Process (RUP) for software development. Responsible for system administration and requirements management for software development.

Established and managed the eToys.com Project Management Office (PMO), developed project management methodologies, established best practices and managed software development projects. Led demand management, eCommerce stress testing, and software quality projects.

Validation Coordinator and Lead on software development projects at Eli Lilly.