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Product Labeling Operations Project Manager

Company: W.L. Gore & Associates
Location: Phoenix
Posted on: February 12, 2024

Job Description:

About the Role: We are looking for a Product Labeling Project Manager to join our team. In this role, you will develop and manage labeling that is compliant with requirements of US FDA, European Notified Body and other global regulatory bodies as appropriate. You will work in conjunction with regulatory, quality, operations, technical and product development teams.

This position can be based at one of our facilities in Phoenix of Flagstaff, AZ with the possibility of a hybrid remote work arrangement, depending upon the responsibilities of the role and business needs.

Responsibilities:

  • Manage product label creation, approval, production and implementation for new product development and the maintenance of the existing commercial product portfolio
  • Work with regulatory and quality assurance to ensure product labeling is compliant with global medical device requirements
  • Work effectively with diverse cross-functional teams to manage changes to print and electronic product labeling components - including management of all levels of product labeling content, graphics, production, and language translations through review and approval, to production and implementation on the manufacturing floor
  • Develop and maintain a strategy for process improvement and influencing cross-functional teams to take action
  • Provide training and coaching other associates on product labeling processes and provide direct feedback to mentor and develop others through equitable and inclusive behaviors
  • Develop and execute project plans to achieve defined milestones and timelines, and effectively communicate those plans to the proper stakeholders throughout the project duration
  • Collaborate with other product labeling project managers to drive global functional excellence
  • Develop product labeling strategies and project plans to meet the requirements of a dynamic global market
  • Work with product teams, regulatory, quality, technical, procurement, planning, distribution, inventory and logistics associates toward continuous improvement goals
  • Stay current with medical device labeling requirements and regulations, barcode technologies, industry trends and best practices

    Required Qualifications:
    • Bachelors degree and a minimum of 2 years of project-management experience OR a minimum of 5 years of project-management experience
    • A strong knowledge of working within manufacturing/quality assurance systems such as Good Manufacturing Practices (GMPs) and ISO 9000
    • Proven ability to effectively interact with and influence manufacturing, quality assurance, regulatory, product team, technical and operations associates, as well as external suppliers
    • Working knowledge of standard business software, specifically Microsoft Word, PowerPoint, Excel and Project
    • Demonstrated attention to detail, particularly in project work
    • A work style of hands-on involvement in all phases of projects
    • Track record of working effectively in team situations as well as independently to prioritize, plan, and drive multiple projects to successful completion concurrently
    • Excellent oral and written communication and interpersonal skills, including conflict resolution
    • Ability to travel up to 10%

      Desired Qualifications:
      • Experience working within a regulated industry
      • PMP Certification #LI-ASC

        Hybrid Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore's hybrid working policies, from the country in which they are employed.

        What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.

        We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for "profit-sharing". Learn more at gore.com/careers/benefits

        We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.

        Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.

        Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.

        Gore requires all applicants to be eligible to work within the U.S. Gore generally will not sponsor visas unless otherwise noted on the position description.

        Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact

Keywords: W.L. Gore & Associates, Phoenix , Product Labeling Operations Project Manager, Executive , Phoenix, Arizona

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