SAP Business Solutions Leader

At the forefront of transformative medicine, our organization is driven by a relentless pursuit of bold science. Founded in 1997, we have leveraged our expertise in understanding genetic conditions to create innovative medicines that address significant unmet medical needs. Our teams are empowered to pursue cutting-edge research, fostering an environment of collaboration and innovation.

We take pride in our Technical Operations group, responsible for developing and scaling production of our drugs for clinical trials and commercial markets. This team of skilled engineers, technicians, scientists, and support staff ensures seamless manufacturing processes, quality assurance, and regulatory compliance. They work tirelessly to procure necessary goods and services, coordinating the global movement of our drugs to patients worldwide.

Overview:

We are seeking a seasoned SAP Business Analyst Lead to spearhead the Plan to Produce workstream, focusing on Manufacturing (In-house and Contract), Quality Control, and Quality Assurance within a GxP-regulated environment. The successful candidate will drive integration of processes across critical subsystems, including SAP, Laboratory Information Management Systems (LIMS), Warehouse Management Systems (WMS), Manufacturing Execution Systems (MES), and Quality Management Systems (QMS). This role demands excellent project management skills, proficiency in MS Project or similar tools, and strong analytical, problem-solving, and communication abilities to bridge business and technical teams.

• Process Leadership & Integration: Design, configure, and implement SAP modules (e.g., PP, QM, MM) to support end-to-end Plan to Produce processes, ensuring seamless operations, compliance, and efficiency.
• Facilitate integration between SAP and subsystems (LIMS, WMS, MES, QMS) to ensure data consistency, process alignment, and real-time visibility across manufacturing and quality operations.
• Collaborate with cross-functional teams to map and optimize business processes, ensuring compliance with GxP standards and regulatory requirements.
• Manufacturing Support: Configure SAP solutions to manage production schedules, capacity planning, and material traceability for both in-house and contract manufacturing operations.
• Ensure SAP configurations align with manufacturing workflows, including batch management, shop floor control, and contract manufacturing processes.
• Quality Control & Assurance: Oversee implementation of SAP Quality Management (QM) module to support quality control and assurance processes in a GxP environment.
• Enable integration with QMS for non-conformance management, CAPA (Corrective and Preventive Actions), and audit trails.
• Ensure traceability and compliance for quality-related data across SAP, LIMS, and QMS systems.
• Stakeholder Collaboration: Act as the primary liaison between business units (Manufacturing, Quality, Supply Chain) and IT teams to translate business requirements into technical specifications.
• Lead workshops, Cross functional Collaboration, requirement-gathering sessions, and solution design reviews to align stakeholders on process improvements and system capabilities.
• Project Management & Delivery: Drive end-to-end project execution, including requirements analysis, solution design, testing, training, and go-live support for SAP and integrated subsystems.
• Develop and maintain project documentation, including business process flows, functional specifications, and test scripts.
• Ensure timely delivery of projects while adhering to budget, scope, and quality standards.
• Continuous Improvement: Identify opportunities for process optimization and system enhancements to improve operational efficiency and compliance.

• Bachelor's degree in Business, Information Technology, Engineering, or a related field; advanced degree preferred.
• 7+ years of experience as an SAP Business Analyst, with at least 3 years in a lead role supporting Plan to Produce processes.
• Expertise in SAP modules such as PP (Production Planning), QM (Quality Management), and MM (Materials Management); experience with SAP S/4HANA is a plus.
• Proven experience integrating SAP with LIMS, WMS, MES, and QMS in a manufacturing or life sciences environment.
• Strong understanding of GxP regulations (e.g., 21 CFR Part 11, GMP) and their application to manufacturing and quality processes.
• Experience with in-house and contract manufacturing workflows, including batch management and material traceability.
• Excellent project management skills, with proficiency in tools like MS Project, Jira, or similar.
• Strong analytical, problem-solving, and communication skills to bridge business and technical teams.
• SAP certifications (e.g., SAP PP, QM, or S/4HANA) are highly desirable.

• Knowledge of Industry 4.0 technologies, such as IoT or automation, in manufacturing environments.
• Familiarity with data analytics and reporting tools (e.g., SAP Analytics Cloud, Data Sphere Power BI) for process insights.
• Experience with Agile or DevOps methodologies for system implementation.