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.
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.
requirements-expected :
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.
