Serialization Business Analyst

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:

We are seeking a detail-oriented and analytical Serialization Business Analyst to join our team. In this role, you will act as a bridge between technical teams, business stakeholders, and external partners to ensure the successful implementation and optimization of serialization systems. You will play a critical role in driving compliance with global regulatory requirements, enhancing supply chain visibility, and supporting end-to-end product traceability.

Essential Duties and Responsibilities:

•      Business Analysis & Requirements Gathering:

•      Collaborate with stakeholders to understand business needs, identify gaps, and translate requirements into functional specifications.

•      Analyse serialization regulations (e.g EU FMD) and align system capabilities with compliance requirements.

•      Map and document end-to-end business processes, focusing on serialization and traceability workflows.

•      Project Coordination & Stakeholder Management:

•      Work closely with project managers, developers, QA teams, and external solution providers to support serialization system implementations and upgrades.

•      Act as a liaison between business units and IT, ensuring smooth communication and alignment on deliverables.

•      System & Data Management:

•      Assist in the configuration, testing, and validation of serialization systems (e.g, TraceLink, rfxcel ,Track and Trace, IRIS).

•      Support the design and management of master data, serial number generation, and aggregation processes.

•      Troubleshoot serialization issues, coordinate resolution efforts, and recommend process improvements.

•      Documentation & Compliance:

•      Maintain detailed documentation, including business requirement documents (BRDs), functional specs, test scripts, and training materials.

•      Ensure systems and processes align with industry best practices and meet GxP and regulatory compliance standards.

•      Other duties may be assigned. 

Qualifications:

·         Functional and technical knowledge in the area of Serialisation.

·         Team management for internal/external resources based in different regions

·          Ability to communicate and collaborate with other IT professionals and business stakeholders.

·         Proven analytical and problem resolution skills.

·         Proactive responsible individual, able to set own action plans.

·          Communicate status, solutions, and concerns.

·         Establish and maintain strong relationships within the business/IT leadership.

·          Strong oral and written communication skills.

·         Process oriented and committed to superior quality.

·         Ability to travel within and outside of the EMEA region.

·         Ability to search for innovative solutions and find ways to overcome obstacles.

·         Ability to develop functional specifications.

·         Positive and Quick Learning attitude.

·         Ownership and Leadership driving to completion.

·         Team Player and support constructive debate.

·         Understand and follow appropriate SDLC & quality validation processes.

Education and Experience

·         Bachelor’s degree in related field required.

·         5 - 10+ years of Serialisation experience.

·         Experience working with technology vendors.

·         Experience in project management

·         Expertise in healthcare and connected technology solutions.

·         Experience in Serialization for pharmaceutical environment

·         Knowledge of IT governance and operations.

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.