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Senior Business Analyst with GxP

Senior Business Analyst with GxP

SQUARE ONE RESOURCES sp. z o.o.Warszawa, mazowieckie, Polska
11 days ago
Job description

Senior Business Analyst with GxP

Miejsce pracy : Warszawa

Technologies we use

Expected

Optional

  • Java

About the project

We are seeking a Senior Business Analyst with extensive experience in GxP (Good Practice) regulations to support a strategic project focused on batch release and certification processes.

The ideal candidate will have a strong background in SAP (particularly the QM module) and a proven track record of leading cross-functional teams.

As a Senior Business Analyst, you will be responsible for leading a team of Business Analysts, managing the system support and optimization for batch release processes, and ensuring compliance with industry regulations.

Your responsibilities

  • Lead, mentor, and develop a team of Business Analysts, ensuring a high level of performance and motivation.
  • Assign tasks, manage workloads, and monitor team productivity.
  • Conduct performance reviews, provide constructive feedback, and help foster a collaborative and high-performing environment.
  • Elicit, analyze, and document complex business requirements for batch release and certification processes.
  • Lead workshops and interviews with senior stakeholders to understand pain points, current processes, and future needs.
  • Translate business requirements into functional specifications, user stories, and process flows, aligning them with the strategic objectives of the organization.
  • Oversee support for IT systems related to batch release and certification, ensuring issues are resolved efficiently.
  • Identify and implement process improvements and system enhancements to increase operational efficiency and compliance.
  • Collaborate with IT leadership to plan and execute major system changes and upgrades.
  • Serve as the key liaison between senior business stakeholders and IT leadership, ensuring clear communication and alignment.
  • Develop and deliver high-level training materials and documentation for end-users and stakeholders.
  • Lead project meetings, providing executive-level updates on progress, challenges, and solutions.
  • Ensure all processes and systems comply with relevant regulations and Roche’s quality standards.
  • Provide expert guidance on GxP compliance matters, ensuring audit readiness and adherence to industry standards.
  • Lead support for audits and inspections, ensuring thorough preparation, follow-up, and continuous improvement.
  • Stay up-to-date with industry trends and regulatory changes, providing strategic recommendations.
  • Our requirements

  • Minimum of 6 years of experience as a Business Analyst in a GxP-regulated environment.
  • Strong knowledge of GxP principles and their application in the life sciences industry.
  • Basic understanding of SAP, with a preference for experience with the SAP QM (Quality Management) module.
  • Proven ability to work across teams and manage stakeholder expectations effectively.
  • Experience in leading and mentoring teams of Business Analysts.
  • Strong analytical and problem-solving skills with the ability to handle complex requirements and projects.
  • Highly organized and self-motivated, capable of working independently and managing competing priorities.
  • Optional

  • Experience working at Roche or in a similar life sciences organization.
  • Knowledge of Java-based custom applications.
  • This is how we organize our work

    This is how we work

  • in house
  • you have influence on the technological solutions applied
  • you focus on product development
  • scrum
  • This is how we work on a project

  • documentation
  • issue tracking tools
  • technical debt management
  • functional tests
  • integration tests
  • performance tests
  • testing environments
  • manual tests
  • Recruitment stages

  • Technical Interview : The interview will focus on your GxP expertise, SAP experience, and leadership abilities.
  • SQUARE ONE RESOURCES sp. z o.o.

    At Square One Poland we link IT experts with the business. With over 25 years of experience, we specialize in recruitment processes on a global scale. Despite years of experience, we still have a startup DNA and this is our advantage. Our offices are located in London and Warsaw, however, we can reach clients from all over the world, from start-ups to big worldwide corporations.

    Klikając w przycisk „Aplikuj” lub w inny sposób wysyłając zgłoszenie rekrutacyjne, zgadzasz się na przetwarzanie Twoich danych osobowych przez SQUARE ONE RESOURCES sp. z o.o. z siedzibą w : Puławska 2, 02-566 Warszawa (Pracodawca), jako administratora danych osobowych w celu przeprowadzenia rekrutacji na stanowisko wskazane w ogłoszeniu.

    Twoje dane osobowe będą przetwarzane w oparciu o następujące podstawy prawne : (a) aby podjąć działania na Twoje żądanie przed zawarciem umowy (np. informacje o oczekiwanym wynagrodzeniu i dostępności do rozpoczęcia pracy); (b) w oparciu o nasz prawnie uzasadniony interes (np. imię, nazwisko, data urodzenia, dane kontaktowe, wykształcenie, kwalifikacje zawodowe, przebieg dotychczasowego zatrudnienia); c) w oparciu o Twoją zgodę, która wyrażona jest poprzez przeslanie dokumentów aplikacyjnych zawierających takie informacje jak np. wizerunek czy zainteresowania. Podanie wszystkich danych osobowych, o których mowa powyżej jest dobrowolne, natomiast dane wymienione w lit. a) i b) są niezbędne do wzięcia udziału w rekrutacji. Niepodanie danych skutkuje brakiem możliwości rozpatrzenia kandydatury. Podanie pozostałych danych jest dobrowolne, ale może pomóc w sprawnym przeprowadzeniu procesu rekrutacji. Masz prawo żądać dostępu do Twoich danych (w tym uzyskania ich kopii), sprostowania danych, ich usunięcia, ograniczenia przetwarzania, przeniesienia, jak również wniesienia sprzeciwu wobec ich przetwarzania. Masz także prawo wniesienia skargi do Prezesa Urzędu Ochrony Danych Osobowych. Twoje dane osobowe mogą zostać przekazane dostawcom usługi publikacji ogłoszeń o pracę, dostawcom systemów do zarządzania rekrutacjami, dostawcom usług IT (hosting), dostawcom systemów informatycznych. Podane przez Ciebie dane osobowe nie będą wykorzystywane w celu profilowania albo podejmowania decyzji w sposób zautomatyzowany. Twoje dane osobowe będą przetwarzane przez okres maks. 1 roku od zakończenia publikacji ogłoszenia, chyba, że wyraziłeś odrębną zgodę na wykorzystanie Twoich danych osobowych w przyszłych rekrutacjach. W celu realizacji praw lub w przypadku jakichkolwiek pytań związanych z przetwarzaniem Twoich danych osobowych skontaktuj się z nami pod adresem : plinfo@squareoneresources.com.

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    Senior Analyst • Warszawa, mazowieckie, Polska

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