Sr Manager – IT Business Analysis – SAP BRH Architect

Sr Manager – IT Business Analysis – SAP BRH Architect

Requirements

• Bachelor’s Degree and 8 Years’ Experience OR Master’s Degree and 6 Years’ Experience OR PhD
• 8+ years of experience with SAP, specifically in SAP QM (Quality Management), overall Quality Management process and preferably within the Biotech / Pharmaceutical industry.

Responsibilities

• Lead the architecture, design, and implementation of SAP BRH solutions tailored for Life Sciences manufacturing operations, ensuring alignment with industry regulations such as GxP, FDA, and 21 CFR Part 11.
• Develop and articulate a comprehensive SAP Batch Release Hub (BRH) solution roadmap that aligns with the company’s long-term business objectives within the Life Sciences sector.
• Architect scalable and flexible SAP solutions that can adapt to evolving business requirements and regulatory landscapes.
• Conduct detailed gap analyses and propose innovative solutions to optimize processes of SAP BRH and integrations.
• Evaluate and recommend emerging SAP technologies and best practices to enhance system performance and efficiency.
• Produce detailed architectural blueprints, including data flow diagrams, system interface specifications, and configuration documentation.
• Oversee the deployment of SAP BRH for batch release management.
• Lead the entire implementation lifecycle, including requirements gathering, system design, configuration, testing, and deployment.
• Work closely with business teams to ensure the solution meets operational and regulatory needs.
• Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to design SAP BRH solutions that optimize batch release processes.
• Ensure that all SAP BRH solutions comply with relevant Life Sciences industry regulations, including GxP, FDA, EMA, and other regulatory bodies.
• Lead the development of validation strategies and documentation to support compliance efforts.
• Ensure seamless integration between SAP BRH and other SAP modules, including SAP S/4HANA, SAP PLM, QM, SAP EWM, SAP PP, and third-party systems, ensuring end-to-end traceability and batch data management.
• Lead the configuration and customization of SAP BRH to align with specific business needs.
• Ensure proper setup of batch release workflows, document management, quality control checks, and reporting.
• Provide ongoing support and troubleshooting for SAP BRH solutions, resolving issues related to system performance, batch release workflows, and integration with other modules.
• Work closely with IT and business teams to identify and implement continuous improvements.
• Work with stakeholders across IT, business operations, quality assurance, and regulatory teams to define and prioritize requirements.
• Communicate technical concepts to non-technical stakeholders and ensure project milestones are met.
• Ensure all SAP PP/QM solutions comply with relevant regulatory requirements, including GMP, FDA 21 CFR Part 11, and other applicable standards.
• Partner with Validation teams to develop and maintain validation documentation, including validation plans, test scripts, and traceability matrices.
• Build and lead a high-performing team of SAP professionals, providing clear direction, coaching, and mentorship.
• Conduct regular performance evaluations and provide constructive feedback to team members.
• Foster a culture of continuous learning and professional development. Promote teamwork and collaboration, encouraging knowledge sharing and best practice adoption.
• Stay up-to-date with industry trends, SAP updates, and regulatory changes.
• Actively seek opportunities to improve the batch release process, streamline operations, and enhance system efficiency.

Preferred Qualifications

• Proven experience in SAP solution architecture S/4 HANA, BTP (Business Technology Platform) and leadership roles, including overseeing end-to-end project lifecycles.
• Strong understanding of manufacturing, quality control, and supply chain processes within SAP.
• Expertise in implementing and configuring SAP BRH solutions, particularly in regulated environments such as pharmaceutical, biotech, or medical device manufacturing.
• Experience with SAP S/4HANA and integration with other SAP modules (PLM, MM, PP, QM, EWM) & Non-SAP modules (QMS, LIMS, MES, RIMS).
• Experience with batch release workflows, document management systems, and quality management processes in Life Sciences.
• Master’s degree or relevant certifications (e.g., SAP Certified Application Associate in S/4 HANA and/or SAP BTP) is a plus.
• Expertise in SAP BRH architecture, configuration, and implementation.
• Hands-on experience with SAP S/4HANA and related modules (MM, PP, QM, EWM).
• Knowledge of SAP integration tools such as, CPI, IDocs, BAPIs, and Web Services.
• Familiarity with cloud technologies and integration (e.g., SAP Cloud Platform BTP) is a plus.
• Strong understanding of SAP’s batch management, lot traceability, and quality control features.
• Strong project management skills, with experience leading cross-functional teams.
• Deep knowledge of industry best practices in manufacturing, production, and quality management.
• Solid understanding of the Life Sciences industry, specifically the challenges and regulatory considerations related to batch release, manufacturing, and quality assurance processes.
• Familiarity with GxP (Good Manufacturing Practices), FDA regulations, 21 CFR Part 11, and other relevant industry standards.
• Strong leadership, problem-solving, and analytical skills.
• Excellent communication skills with the ability to translate technical concepts into business language for stakeholders at all levels.
• Ability to work under pressure in a fast-paced environment and manage multiple projects simultaneously.
• Strong team player with a collaborative mindset.