Architect, facilitate, and own end to end labeling process definition, governance, performance, and continuous improvement across the Edwards enterprise. Provide expertise in development of technical solutions to optimize processes and systems.
Partner with the Quality liaison to identify, assess, develop, implement and own regulatory and standards compliant processes, procedures and controls intended to implement released labeling in manufacturing and distribution operations, in collaborative partnership with Quality, GSC, Regulatory, IT and Labeling design process owner.
* Configure and test solutions to execute features, integrations/dependencies, and reporting.
* Partner with 3PL and Manufacturing site managers to develop print and apply strategies and ensure process compliance & performance that continually meets evolving compliance and productivity needs.
* Drive/facilitate the development and implementation of streamlined and compliant print and apply (including supplemental labeling at 3PLs) strategies, processes, procedures, global standards (assets, labels, systems), and performance monitoring.
* Establish strong relationships with the labeling function's stakeholders in Global Supply Chain, Quality, Regulatory, IT and Marketing.
* Provide guidance to project teams for current and proposed solutions, and best practices training for users, superusers and administrators during implementation and execution.
* Ensure compliance with established patterns and practices on projects/initiatives including technical implementation during development efforts. Add and update content in solution documentation.
* Active membership on project teams to translate business requirements to solutions and integrations. Solution ownership where appropriate.
* Identify and recommend innovations that significantly enhance efficiencies and effectiveness of business processes
* Manage global initiatives including system implementations and process changes in Labeling to comply with industry standards and global regulatory agency requirements, including, but not limited to, scoping requirements, establishing project teams, software/system selection, LEAN process improvements, and related changes to standard operating procedures.
* Form and direct global cross-functional teams, developing detailed project plans, delegating tasks to team members, ensuring tasks and deliverables are completed by due dates, leading or participating in appropriate process and functional meetings, assessing gaps between current state and future requirements, updating stakeholders, senior management, and other team members with project status, issue resolution and executive briefings.
* Accountable for meeting agreed upon scope, cost, schedule and quality measures.
* Work with global sites and IT to define and maintain Global Standards (incl. assets, labels, systems).
* Work with IT to define the new systems / solutions and oversee the completion, accuracy and testing of them.
* Partner with Quality to ensure processes are developed and controlled ensuring compliance.
Typical Experience and Education:
* Bachelor's degree required with a minimum of 8 years experience in one of the following areas: management, manufacturing, operations, engineering, or transfers preferred.
* Understanding of interdependencies of Labeling Technology and Solutions
* Continuous Improvement of processes and systems and development of process improvement skills (Green and Black belts)
* Knowledge of medical device documentation development activities
* Managing large initiatives including scope, budget and resources
* Ability to identify, develop and implement processes, procedures & controls that result in effective processes compliant with regulatory and industry standards.
* Excellent interpersonal, relationship management, and written & oral communication skills, with demonstrated ability to communicate both technical and business information to audiences across cultural boundaries
* Project management and project management software tools, PMP Certification preferred.
* Skills in decision-making and taking initiative.
* Ability to function well under pressure and balance multiple projects.
* Ability to travel globally up to 35% of the time, depending on project phase and scope
About Edwards Lifesciences
Edwards Lifesciences is a company operating as a global provider of patient-focused medical solutions for structural heart disease and critical care monitoring.