Johnson & Johnson
Labeling Project Leader
Labeling Project Leader
Location: Leiden, Netherlands - Hybrid working
Duration: 12 months
Hours: 40 hours per week
Imagine your next project working as a Labeling Project Leader for Johnson & Johnson! Accountable for new product and lifecycle labeling project portfolio management. Responsible for lifecycle label change requests and accountable for end-to-end execution of labeling changes in support of artwork only changes. Support the labeling changes that drive business unit objectives and strategies, regulatory and compliance requirement changes and supply chain strategies.
roles and responsibilities
Point person for business units in developing labeling strategies, project plans and executing project plans. Engaged with business units directly and represents labeling function.
Lead the New Product and Lifecycle Labeling Project Portfolio Review Process which includes a cadence of obtaining project requests, participating in Business Unit Lifecycle team governance, and leading cross-functional team to review the projects’ business case, conduct risk analysis and develop recommendations for approval, priority and project change governance.
Partner with PM Lifecycle Product Manager, Quality, Regulatory, Marketing associates for prioritization and execution strategies.
Represent Lifecycle Labeling Portfolio recommendations to appropriate governance bodies for approval of recommendations. Ensure stakeholders understand outputs of all decisions and track project status.
Maintain product label design and process knowledge for those platforms responsible.
Represent Labeling within local design change control process.
Accountable for executing Design Change documentation and execution for label only changes.
Responsible for leading collaboration for impact analysis, alignment on scope and changing label content with Regulatory, Clinical, Quality, R&D and Product Management as required.
Responsible for supervising internal and/or contracted associates to complete Label Design Change documentation and execution through the label change.
Accountable for working with planning for phase in/phase out of changes considering commercial, quality or regulatory strategies and insuring implementation.
Review and approve documents representing Labeling as outlined per local quality system procedures as appropriate.
Lead projects as appropriate for unplanned event responses or planned changes. Accountable for integrating and coordinating impact analysis, response development, communications planning, and execution associated with unplanned events that impact continuity of quality supply.
Develop & execute multi-generational project planning (MGPP) strategies to meet quality, compliance, delivery and cost goals.
Lead and/or support CAPAs as required.
Know & follow local Quality System policies & procedures
Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments & for implementation of new policies & procedures. Complete required periodic re-training in areas such as safety and environmental.
Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter work area
Ensure multi-project coordination of changes for assigned business units.
Represent Labeling as a site lead
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
how to succeed
Bachelor’s Degree Required in an Engineering or Design discipline.
Project Management Professional Certification preferred
Green Belt certification is preferred
Minimum of five year’s experience in Labeling Projects, Operations, Engineering, Quality, Compliance, Regulatory and/or equivalent with significant project and leadership accountabilities.
Demonstrated successful completion of developing and leading several process, technical and/or business challenges
Demonstrated ability to lead a cross-functional team. Cross company, cross region team preferred.
Demonstrated understanding of the Medical Device or equivalent regulated industry, Quality Systems and Change Control procedures would be preferred.
Experience in a New Product Development project or Lifecycle Project is preferred.
Demonstrated leadership of several complex projects delivering results
Demonstrated leadership of change management initiative
Demonstrated ability to manage complexity
Demonstrated ability to identify risks and create mitigation solutions
Demonstrated initiation of new ideas and continuous improvement
Demonstrated track record of Project Management
Conflict Management
Advanced proficiency with written and verbal communications
Technical Writing skills and experience preferred.
Demonstrated track record of Leadership results
Demonstrated Change and Stakeholder Management
Demonstrated understanding of compliance requirements for medical devices and labeling preferred
Business and financial acumen
Customer focused with a good understanding of our customer and commercial stakeholder needs
Demonstrated understanding of an end-to-end Supply Chain, Global Surgery knowledge is preferred
Process Six Sigma
Design and Change Control
PLM System and ERP System knowledge, Adaptiv, Windchill or EpiCenter and JDE ERP preferred
Understand Manufacturing Packaging and Labeling processes
Influence Management in a matrix environment
Labeling Design and development process preferred knowledge
Demonstrated leadership of projects with cross functional teams preferred
Proficiency with MS Office
Proficiency with Microsoft Project, Microsoft Visio and Adobe Illustrator.
Basic process knowledge about packaging machines (Flow Wrap and Cartoning)
benefits
This role offers a very competitive hourly rate. This contract will run for 12 months with a good chance of extension!
you are welcome here
Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
about Mentor, Leiden
Part of Johnson & Johnson, Mentor sells and produces breast implants for reconstruction and augmentation purposes worldwide from their state of the art site in Leiden. With a proud history as a global leader in breast aesthetics, we believe that innovation should be driven by what patients need and should be backed by solid research, high design and thorough testing. Contribute to the next healthcare breakthrough with your next project at Mentor.
application process
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.