Product Transformation Office (PTO) Device Solution Lead

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Summary

As the Device Solution Lead, you will be part of the Global PTO organization and will work with a team of 13 people ensuring the successful transition of drug and medical device label changes driven by the Evergreen Program (Vantive separation from Baxter).

You will report to Global PTO Device Lead and be part of the Planning & Fulfillment organization.

On a day to day basis, you will be part of a cross-functional team including Regulatory Affairs, Labeling, Planning, Procurement, Manufacturing, Quality Assurance and Fulfilment at the UCAN / regional level and you will ensure that team members effectively work together from planning through execution of the labeling changes at the country-code level.

Product Transition required a dedicated team, beyond just standard labelling operations, due to:

•            More than 2000 drugs and device SKUs, all requiring label changes, which equals 11,000 country code combinations that need to transition (globally)

•            There are multiple types of changes and multi-touch levels of changes when navigating the complex and varying regulatory requirements globally (branding, GTIN, code, MDR, for ex.)

•            There are downstream activities, PTO needs to tightly coordinate plant and warehouse capacities, supplier ability, manufacturing timing, etc.

•            Shared codes across multiple markets and optimizing timing of label changes to minimize the number of changes

The role will ensure no patients or customers are impacted in any markets where Vantive products are sold / distributed due to the Evergreen label transition process.

Essential Duties and Responsibilities.  This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned:

• Oversee planning of label changes to 10,000+ country-codes from 14 plants

• Coordinate with plant teams on execution timelines in accordance with regulatory and MDR timelines

• Hold workshop series with individual plants to confirm first-of-code with new label by end of September

• Work together with 1 device planning FTEs, 1 MDR liaison, and 1 data analyst to support planning workshops for each plant, compile feedback into PTO device files, & develop reporting to ISC/SMO/SteerCo

• Collaborate with stakeholders to understand business requirements and pain points, and user stories translating them into innovative solutions that address risks, process bottlenecks and foster continuous improvement.

• Collaborate with the cross-functional team to build project requirements ensuring the proposed solution will meet business needs.

• Lead functional discovery and functional process workshops / working session.

• Drive change through exceptional communication with management, stakeholders, and team members.

• Work directly with Leads to develop, coordinate, integrate and consistently implement best practices globally.

• Perform special projects and other duties as assigned.

Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

• Strong project management skills and the ability to ensure timelines stay on task

• Deep understanding of the processes to implement label updates and can organize cross-functional teams in their implementation

• Leads well with indirect authority due to interdependencies with MDR team

• Strong delegation skills to ensure team members can grow and effectively use their own skills

• Team player mentality with the capacity to lead and contribute to cross-function initiatives.

• Must be able to work independently with minimal supervision and can work with an appreciable amount of latitude.

• Good planning and project management skills.

Education and/or Experience.  Include the education and/or experience that is necessary to perform the job satisfactorily.

• Educational Background: Bachelor’s degree in Engineering, Business, Finance, Data Science, Computer Science, Mathematics, or related field or equivalent experience

• Experience: 3 or more years of experience in Supply Chain, healthcare services and/or specialty pharmacy service

• 2+ years of Experience working on large-scale or multi-faceted projects

• Industry Knowledge: Experience in the healthcare sector preferred.

• Communication: Must be able to effectively interact and communicate with all levels of management and employees within the company.

• Technical: Strong working knowledge of Microsoft Office Suite

• Lean/six sigma training and certification preferred.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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