Gilead
Sr Manager, IT Business Analysis - SAP BRH Architect
Gilead, San Mateo, California, United States, 94404
SAP Batch Release Hub Architect
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer
working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases. We are seeking an experienced SAP Batch Release Hub (BRH) Architect with a strong background in Life Sciences to lead the design and implementation of SAP Batch Release Hub solutions. The ideal candidate will possess deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA), and life sciences Quality Management and Batch Release processes. As an SAP BRH Architect, you will play a critical role in designing and optimizing solutions for batch release processes, ensuring seamless integration with SAP S/4HANA and other related systems (QMS, LIMS etc.,) and driving business process excellence in a regulated environment. This role involves strategic oversight and technical expertise in SAP systems, working closely with cross-functional teams to enhance manufacturing processes, quality management, and overall system integration. Strategic Solution Architecture & Design: 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.
SAP BRH Implementation: 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.
Batch Release Process Optimization: Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to design SAP BRH solutions that optimize batch release processes.
Regulatory Compliance: 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.
Integration with SAP & Non-SAP Modules: Ensure seamless integration between SAP BRH and other SAP modules, including SAP S/4HANA, SAP SAP PLM, QM, SAP EWM, SAP PP, and third-party systems, ensuring end-to-end traceability and batch data management.
Configuration & Customization: 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.
Troubleshooting & Support: 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.
Stakeholder Engagement: 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.
Stringent Compliance & Regulatory Adherence: 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.
Inspiring Team Leadership & Mentorship: 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.
Continuous Improvement: 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.
Basic Qualifications: Bachelor's Degree and 8 Years' Experience OR Master's Degree and 6 Years' Experience OR PhD and 8+ years of experience with SAP, specifically in SAP QM (Quality Management), overall Quality Management process and preferably within the Biotech / Pharmaceutical industry.
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
Experience with SAP S/4HANA is required.
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).
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer
working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases. We are seeking an experienced SAP Batch Release Hub (BRH) Architect with a strong background in Life Sciences to lead the design and implementation of SAP Batch Release Hub solutions. The ideal candidate will possess deep expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA), and life sciences Quality Management and Batch Release processes. As an SAP BRH Architect, you will play a critical role in designing and optimizing solutions for batch release processes, ensuring seamless integration with SAP S/4HANA and other related systems (QMS, LIMS etc.,) and driving business process excellence in a regulated environment. This role involves strategic oversight and technical expertise in SAP systems, working closely with cross-functional teams to enhance manufacturing processes, quality management, and overall system integration. Strategic Solution Architecture & Design: 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.
SAP BRH Implementation: 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.
Batch Release Process Optimization: Collaborate with cross-functional teams, including manufacturing, quality control, and regulatory affairs, to design SAP BRH solutions that optimize batch release processes.
Regulatory Compliance: 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.
Integration with SAP & Non-SAP Modules: Ensure seamless integration between SAP BRH and other SAP modules, including SAP S/4HANA, SAP SAP PLM, QM, SAP EWM, SAP PP, and third-party systems, ensuring end-to-end traceability and batch data management.
Configuration & Customization: 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.
Troubleshooting & Support: 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.
Stakeholder Engagement: 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.
Stringent Compliance & Regulatory Adherence: 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.
Inspiring Team Leadership & Mentorship: 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.
Continuous Improvement: 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.
Basic Qualifications: Bachelor's Degree and 8 Years' Experience OR Master's Degree and 6 Years' Experience OR PhD and 8+ years of experience with SAP, specifically in SAP QM (Quality Management), overall Quality Management process and preferably within the Biotech / Pharmaceutical industry.
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
Experience with SAP S/4HANA is required.
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).