We are seeking a highly skilled Senior Business Analyst to support the MPC and S4 assessment with a focus on business processes, batch release, and certification.

This role requires deep knowledge in GxP compliance, basic SAP QM module understanding, and strong leadership and analytical skills to guide a team of Business Analysts.

The position involves direct involvement with business stakeholders and IT teams, ensuring a balance of strategic vision with hands-on execution.

Senior Business Analyst

Your responsibilities

• Lead, mentor, and develop a team of Business Analysts.
• Assign tasks, manage workload, and ensure team productivity.
• Conduct performance reviews and provide constructive feedback to team members.
• Foster a collaborative and high-performing team environment.
• Elicit, analyze, and document complex business requirements for batch release and certification processes.
• Conduct workshops and interviews with senior business stakeholders to identify current challenges and future needs.
• Translate business requirements into functional specifications, user stories, and process flows in alignment with strategic goals.
• Oversee the support for IT systems related to batch release and certification processes.
• Identify opportunities for process improvements and system enhancements to drive efficiency and compliance.
• Work closely with IT leadership to plan and execute major system changes and upgrades.
• Serve as the primary liaison between senior business stakeholders and IT leadership, ensuring clear communication and alignment of strategic objectives.
• Develop and deliver training materials and documentation for end-users and stakeholders.
• Lead project meetings and provide executive-level updates on project status, issues, and progress.
• Ensure all processes and systems comply with GxP regulations and Roche quality standards.
• Lead preparation for audits and inspections related to batch release and certification.
• Stay up-to-date with industry trends and regulatory changes, providing strategic recommendations for improvements.

Our requirements

• Proven experience as a Senior Business Analyst, ideally in regulated industries such as pharmaceuticals, medical devices, or biotechnology, where strict regulatory compliance is essential.
• Deep understanding of GxP (Good Practices) principles and their practical application in a business context.
• A foundational understanding of SAP Quality Management (QM) module to collaborate effectively with technical teams.
• Strong leadership capabilities to manage and motivate a team.
• Excellent analytical skills to document, analyze, and improve complex business processes.
• Clear communication abilities to lead workshops, explain complex requirements, and interact with business and IT stakeholders effectively.
• SAP Quality Management (QM Module)
• Java-based custom applications