Company: Johnson & Johnson Location: Cincinnati, OH Employment Type: Full Time Date Posted: 07/31/2021 Expire Date: 09/29/2021 Job Categories:
Finance/Economics, Healthcare, Practitioner and Technician, Manufacturing and Production, Sales, Executive Management, Research & Development, Medical, Environmental, Writing/Authoring, Energy / Utilities
Project Manager, Labeling Lifecycle Management
Ethicon Surgical Care, part of the Johnson & Johnson family of companies, is recruiting for a Project Manager, Labeling Lifecycle Management to be located in Cincinnati, OH.
The Ethicon Surgical Care business is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Biosurgery, Ethicon Energy, Ethicon Endomechanics, Ethicon Robotics, Megadyne, NeuWave, and Torax. With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati.
Accountable for 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 and label component content changes. Support the labeling changes that drive business unit objectives and strategies, regulatory and compliance requirement changes and supply chain strategies.
The project manager will partner with business units in developing labeling strategies, project plans and executing project plans. Engages with business units directly and represents labeling function.
Supports the 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.
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 in Change Review Board (CRB) or equivalent within local design change control process.
Accountable for executing Design Change documentation and execution for label 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 process.
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.
Lead and/or support CAPAs as required.
Adhere to 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
Bachelor’s Degree Required. A Masters or other Advanced degree is preferred.
Minimum of 7 years experience in Operations, Engineering, NPD, Quality, Compliance, Regulatory and/or equivalent with project management and demonstrated leadership accountabilities is required
Demonstrated successful completion of developing and leading several processes, technical and/or business challenges is required
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 required
Demonstrated leadership of change management initiative required
Demonstrated ability to identify risks and create mitigation solutions required
Demonstrated initiation of new ideas and continuous improvement required
Project Management Professional Certification preferred
APICS Supply Chain certification preferred
Green Belt certification preferred
Demonstrated track record of Project Management required
Conflict Management experience is required
Technical Writing skills and experience preferred.
Demonstrated track record of Leadership results is preferred
Demonstrated Change and Stakeholder Management is required
Demonstrated understanding of compliance requirements for medical devices and labeling preferred
Business and financial acumen preferred
Customer-focused with a good understanding of our customer and commercial stakeholder needs required
Demonstrated understanding of an end to end Supply Chain, medical device knowledge is preferred
Process Six Sigma preferred
Design and Change Control preferred
PLM System knowledge such as Adaptiv, Windchill or EpiCenter and preferred
Understanding of Manufacturing Packaging and Labeling processes preferred
Ability to Influence Management in a matrix environment required
Labeling Design and development process knowledge preferred
Demonstrated leadership of projects with cross-functional teams preferred
Proficiency with Microsoft Projects is required
Ability to quickly learn and become proficient in labeling, PLM, Resource planning tools required
This position will be located in Cincinnati, OH, and may require up to 10% international & domestic travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location United States-Ohio-Cincinnati-4545 Creek Road Organization Ethicon Endo Surgery Inc (6041) Job Function General Administration Requisition ID 2105947037W