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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:

+ 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.

The salary range for this position is: $153,935.00 - $199,210.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf)

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.