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.
• Experience working at Roche or in a similar life sciences organization.
• Knowledge of Java-based custom applications.