Sr. Manager, SAP CGTO Solutions Architect

Arbeitsbeschreibung

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:

• Lead the configuration and customization of SAP CGTO to align with specific business needs.

• Ensure proper setup of Master Data, Treatment Order types and workflows, Flow Versions, iFlows, Event Monitoring, Event Messaging, COI, COC, CPI Integration and Control Tower reporting.

Troubleshooting & Support:

• Provide ongoing support and troubleshooting for SAP CGTO solutions, resolving issues related to system performance, Treatment Order processing, 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 CGTO 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 cell therapy management process, streamline operations, and enhance system efficiency.

Basic Qualifications:

• 12+ Years with High School Diploma or equivalent 10+ Years with AA 8+Years with BS / BA 6+ Years with MS / MA / MBA Computer Science or related discipline is preferred.

• Master’s degree or relevant certifications (e.g., SAP Certified Application Associate in S/4 HANA and/or SAP CGTO and BTP) is a plus.

Experience:

• 8+ years of experience with SAP, specifically in SAP Order Management and Manufacturing, overall End to End Cell Therapy Management process within the Biotech / Pharmaceutical industry.

• 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 order management, manufacturing, logistics, distribution, quality control, and supply chain processes within SAP.

• Expertise in implementing and configuring SAP CGTO solutions, particularly in regulated environments such as pharmaceutical, biotech, cell therapy manufacturing.

• Experience with SAP S/4HANA and integration with other SAP modules (MDG, SD, MM, PP, QM, EWM, TM) & Non-SAP modules (SFHC, MES, Robar/Bartender)

• Experience with Master Data, Treatment Order types and workflows, Flow Versions, iFlows, Event Monitoring, Event Messaging, COI, COC, CPI Integration and Control Tower reporting processes in Life Sciences

• Experience with SAP S/4HANA is required.

Skills & Competencies:

• Expertise in SAP CGTO architecture, configuration, and implementation.

• Hands-on experience with SAP S/4HANA and related modules (SD, MM, PP, QM, EWM, TM).

• 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 E2E Cell Therapy process, COI, COC, lot traceability, quality control & freight order scheduling features.

• Strong project management skills, with experience leading cross-functional teams.

Industry Knowledge:

• Deep knowledge of industry best practices in order management, manufacturing, production, logistics, distribution and quality management.

• Solid understanding of the Life Sciences industry, specifically the challenges and regulatory considerations related to Cell Therapy management & processes.

• Familiarity with GxP (Good Manufacturing Practices), FDA regulations, 21 CFR Part 11, and other relevant industry standards.

Soft Skills:

• 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.