Guide and inspire teams in the use design thinking best practices in the deliver solutions for customer’s jobs to be done. Build robust funnels of sustainable innovation opportunities and leads teams through their innovation journey from deeply understanding customer pain points to early in market experimentation. Responsible for leading teams through Sprints, using tools and practices that enable an agile organization.

Led a team responsible for developing, implementing, and maintaining a global quality management system, achieving best-in-class customer quality designations.Implemented data-driven decision-making programs to optimize quality and consistency.Facilitated organizational-wide education on root cause analysis best practices.Provided quality systems support to all plants within the global network.Successfully led multiple systems projects, including ERP upgrades, warehouse management systems, and document management systems.

Provided leadership in designing, developing, and implementing key quality management systems and processes, including an Enterprise wide system for tracking audits, nonconformance and CAPA, pathogen and pre-op data. Lead efforts to improve root cause analysis and CAPA competency throughout the organization ahead of FSMA implementationQuality lead for strategic customer, including serving as key process owner for significant clean label driven food evolution projects.Designed & developed reports and KPI dashboards for key food safety and quality data to monitor and improve quality and consistency of products.

The Soccer Parenting Association aims to inspire players by empowering parents. We are working to Make Youth Soccer Better by fostering collaborative relationships between coaches, parents and clubs.

Primary customer contact responsible for quality assurance oversight of product at contract manufacturing organization (CMO).Manage day to day quality assurance activities for three drug substances (APIs) including change control, deviations, corrective/preventive actions, complaints, and batch release.Manage QA activities for entire API supply chain, including raw materials, consumables, qualified testing labs and qualified storage facilities. This includes site assessments, due diligence audits, formal site qualifications, negotiation of quality and supply agreements and roles and responsibilities matrices. Manage vendor audits, including mock audits, audit back room management, and implementation of audit responses and action plans for manufacturing sites and service providers.Worked with CMO to develop and implement a site improvement plan aimed at improving maturity of quality systems and address challenging regulatory observations.

Managed communications strategy (regulatory and commercialization) throughout the clinical development lifecycle.Responsible for writing study protocols and final reports; submissions to the FDA and EU and right-to-operate documents.

Primary technical custodian (project manager, technical expert) for multiple sterile parenteral products, including facility’s largest and highest grossing client. In this role, I developed, reviewed and/or approved production and packaging master batch records, standard operating procedures, deviation reports, corrective action/preventive action plans, technical requirements document, technical services study protocols and reports, production raw data (including environmental monitoring reports and sterilization cycle reports), and change control documentation

Creation, modification, and multiple language translation of Clinical Trial Investigator Manuals Active participant of multiple client focused project technical teamsExperience with SOPs, statement of work, and study protocols