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.
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.
requirements-expected :
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.
