Sr. Manager, SAP CGTO Solutions 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.

Job Description
 

Sr Manager, SAP CGTO Solutions Architect

Job Overview:

We are seeking an experienced SAP Cell and Gene Therapy Orchestration (CGTO) Architect with a strong background in Life Sciences to lead the design and implementation of SAP CGTO solutions. The ideal candidate will possess deep expertise in SAP CGTO & SAP SD, MM & PP modules, regulatory compliance (such as GxP and FDA), and life sciences Quality Management and Batch Release processes. As an SAP CGTO Architect, you will play a critical role in designing and optimizing solutions for Cell therapy order management, production, batch release & distribution processes, ensuring seamless integration with SAP S/4HANA and other related systems (SFHC - upstream, MES, Robar/Bartender - downstream) 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.

Responsibilities:

Strategic Solution Architecture & Design:

• Lead the architecture, design, and implementation of SAP CGTO solutions tailored for Life Sciences manufacturing operations, ensuring alignment with industry regulations such as GxP, FDA, and 21 CFR Part 11. Design scalable, efficient, and compliant solutions for the End to End Cell Therapy process.

• Develop and articulate a comprehensive SAP Cell and Gene Therapy Orchestration 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 CGTO and integrations, including COI (Chain of Identity) and COC (Chain of Custody)

• 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 CGTO Implementation:

• Oversee the deployment of SAP CGTO for End to End processing of Cell Therapy 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.

CGT Process Optimization:

• Collaborate with cross-functional teams, including patient onboarding, order management, manufacturing, quality control, and regulatory affairs, to design SAP CGTO solutions that optimize Kite’s Cell Therapy process

Regulatory Compliance:

• Ensure that all SAP CGTO 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 CGTO and other SAP modules, including SAP S/4HANA, SAP MDG, SAP QM, SAP EWM, SAP PP, SAP TM, and third-party systems (Sales Force, MES, Robar/Bartender) ensuring end-to-end traceability of COI & COC.

Configuration & Customization: