Senior Business Analyst with GxP

2 dni temu

Warszawa, Mazovia, Polska Square One Resources Sp. z o.o. Pełny etat 42 000 zł - 96 000 zł rocznie

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.

Senior Business Analyst with GxP

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.
  • Knowledge of Java-based custom applications.

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