Daniel Hardy Email & Phone Number

Irvine, California, United States

Managed several Quality Management System upgrades and shift to SaaS. Managed Validation System major upgrade in preparation for shift to SaaS and managed Supplier Management System shift to SaaS. Designed & Delivered:An engaing UI/UX that acts like an interactive Visio chart of an Enterprise Architecture allowing the user to see the architecture reveal new, and sunset old, artifacts over time so they can see past, present, and future states as well as integrations to other related systems .Formats: as a SPA (Single-Page Application HTML/Javascript [portable/serverless], also as a PowerApps/SharePoint version) Each Artifact being clickable to reveal: Contact information for Business Owners, Technical Owners, Vendors, and any Support personnel Description of Purpose Technical Details of Configuration Taggable to enable searchable relationships Html configurable text input that allows in line image and video embedding by the user. Links to SharePoint Documents, Videos, other sites, training, etc.Won Edwards Heart Award for Elecronic Systems Gateway AS2 FDA System Integration Message MonitorAutomatically monitored receipt of ESG/CDRH Ack1, Ack2, and Ack3 Messages checking that the messages were within allowable time limits converting between UTC, Eastern & Pacific Standard and Daylight Savings Time, taking into account global local time of the user and flagging any messages that exceeded allowable limits and automatically sent emails to the FDA and affected users for escalation.Won Edwards Heart Award for User Configurable Decision Trees for Complaint SystemThe vendor could not deliver new designs. Designed a new process in the vendor's system keeping Edwards in compliance a week before new regulations went into effect.

Irvine, California, United States

Upgraded the Hardware and made several point increment and major version upgrades of the QMS System in preparation for Shift to SaaS . This had the immediate benefit of better performance and system stability. Once stable and SaaS capable, lead the successful migration to the cloud. Made many fixes and enhancements in the configurable scripting code to be more efficient, robust, and error resilient along with better documentation and error messaging. Helped structure our enhancements in a more defined, prioritized (Business Value), repeatable, Agile methodology on a regular cadence.Accountable for creating, designing, and supporting Edwards Lifesciences’ global quality and compliance applications and infrastructure. Experienced with enterprise functional design, architectural best practices, and implementation for Quality Management System solutions focused on a wide variety of functional areas such as Non-Conformance, Complaints, Corrective and Preventative Actions (CAPA), etc. Providing expert consultation to inform strategic technology and system decisions as well as tactical decisions related to projects.

Fullerton, California, United States

Leading a team of developers in the development of custom software applications by working cross-functionally with business partners, end users, and the executive team members to create dynamic applications that are scalable, support organizational objectives, promote business innovation, and enable new thinking.

Irvine

DevelopedExcel macro that graphically highlitghed the technological pathways from User portal front end to distributed middleware and back end systems based on the parameters in the Agile release in question. This allowed a quick review of affected front end, middleware, and backend systems out of more than 200 systems available on the gloabl network.Developing and reporting Roadmap projects' progress and operational metrics per release to executive management. Tracking efficacy of Release Trains Teams to expected requirement deliverables and coordinating global testing and inputs. Using developed automation tools to perform detailed analysis of live process data.

Irvine, Ca

Developed Excel tools for checking Jira artifacts against testing requirements and Confluence documentation for Release Management Approval.Improving the quality of global cross domain/platform Product releases in a dynamic Agile environment, by mapping systems and services and ensuring all touch points are thoroughly tested and traceable to business requirements.

Brea, Ca

Roles: Business Systems Analyst, Software Developer, Applications Architect, Project Manager, TrainerTransformed manual processes into efficient automated solutions. Managed large scale global enterprise-wide implementations affecting 14,000 users worldwide as well as smaller ad hoc tools or process changes to reduce errors and gain efficiencies in Quality Systems supporting $4+ billion /year in regulated products globally.• Delivered within 1 week a SPA UI/UX matching Customer's sketch, utilizing Restful API Calls for UDI search from other systems.• Successfully developed a system to upload over 3 million records of sales records received as Excel worksheets from a newly acquired company into a custom database to allow querying and reporting for recall purposes within 3 weeks and to make it flexible enough to import any Excel sheets from any future acquisition without needing to change the data structure of the database or application code. Also added the ability for Admins to change SharePoint report output locations, Help documents, support email addresses, and stored queries in case they do need to change how the system runs, all through end-user Admin functions with no recoding required.• Achieved no loss of production capability while completing a 9-month global replacement of the legacy EQMS System supporting 14,000+ users around the world.• Lead a cross-functional team of process owners, and SMEs across various departments and sites for the implementation of the GAMP5 21 CFR Part 11 compliant CAPA and Complaint Modules including User Requirement/Functional Requirement documentation, Test Script generation, Validation, SDLC documentation, User Guide generation & Train the Trainer training. • Created an automated test script writing tool to maintain validation format and ease repetitive task step inclusion. Made data-based requirements gather tool that would aid in test script generation and Trace Matrix formation to support computer systems validation.

Ensured that Biometric Identification Systems used by Law Enforcement, Military, and Intelligence agencies matched system schematics and operated according to system requirements. Worked on systems supporting the FBI's NGIS (Next Generation Identification System replacement for AFIS), also for SPAWAR and DIA. Inspected OEM Mfg sites, and made monthly Corporate Quality Report packages for Safran.

Responsible for gathering user requirements and creating custom Quality Systems for companies regulated by the FDA and notified bodies. Custom configuration of CATSWeb including custom .dlls. to allow GB size file uploads, integration with SAP, AGILE, ORACLE etc. Designed Complaint, CAPA, Non-Conformance, and Inspection Processes. Worked extensively with Electric Reliability Processes and Document Management Processes.

Buena Park, Ca

• Managed the manufacturing quality support functions of over 1 billion dollars worth of OTC Drugs and Vitamins per year at ABG while managing a staff of over 20 direct reports distributed in 6 laboratories in various stages of the manufacturing process. Duties included: personnel reviews, training & staffing, managing the labor and expense budgets, writing & reviewing SOPs, test procedures, responding to Audits by both Competent Authorities (ISO) as well as Regulatory Bodies (FDA, TGA). Also was the system administrator for the Laboratory Information Management System.• Won a lucrative multi-million dollar OEM Pharma Contract by delivering a wireless intranet based instrument interfacing systems for capturing production and lab data that created real-time statistical charting and detailed reports for product labeling claims verification.• Developed a Web-based UI/UX program linking ERP and LIMS information to eliminate unnecessary testing of over 1 billion dollars’ worth of OTC Drugs and Vitamins per year.• Designed a user-configurable Intranet such that cross-functional Green Belt teams could post: free text, files, images, or video clips. This allowed the posting of SOPs with video clips for training purposes. Users were free to edit as they pleased without help from IT.

Ba, Biology

Mba-Technical Management, Information Technology/Business Administration