Senior Manager Lifecycle Labeling in Somerville, New Jersey | DiversityInc Careers
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Senior Manager Lifecycle Labeling

Ethicon Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Lifecyle Labeling Manager, located in Somerville, NJ.

Ethicon 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. 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, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.

The Lifecycle Labeling Manager will be accountable for lifecycle labeling project portfolio management. Point person 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 in support of business unit objectives and strategies, regulatory and compliance requirement changes and supply chain strategies.

Job 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 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 Business Unit PM Director or PM Lifecycle Product Manager, Quality, Regulatory, Marketing associates for prioritization and execution strategies, this role will have a dotted line to the PM Director accountable for the business units being supported.
  • 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 only changes.
  • Responsible for leading collaboration for impact analysis, alignment on scope and changing label content with Regulatory, Clinical, Quality, R&D and FOD as required.
  • Responsible for supervising internal and/or contracted associates to complete 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.



  • Bachelors Degree Required
  • Masters degree preferred. M.B.A. preferred
  • Minimum of eight years of experience in Operations, Engineering, NPD, Quality, Compliance, Regulatory and/or equivalent with significant project and leadership accountabilities.
  • Develop and Lead multiple process, technical and /or business challenges
  • Ability to lead a cross-functional team. Cross company, cross region team preferred.
  • 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.

· People Management and Talent Development Experience

· Leadership of several complex projects delivering results

· Leadership of change management initiative

· Development of business cases

· Ability to analyze and develop strategies

· Ability to handle complexity

· Ability to identify risks and create mitigation solutions

· Initiation of new ideas and continuous improvement


  • Proficiency with MS Office
  • Proficiency with Microsoft Projects, visio
  • Proficiency with Statistical Analysis Software
  • Able to quickly learn and become proficient in labeling, PLM, Resource planning tools


Frequent travel up to 20%, including internationally. Some travel may be on short notice.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location
United States-New Jersey-Somerville
Ethicon Inc. (6045)
Job Function
Process Engineering
Requisition ID