Sr Manager IT Business Analysis - SAP BRH Architect

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were 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

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 lifethreatening 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 crossfunctional 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. Design scalable efficient and compliant solutions for the batch release process.

• Develop and articulate a comprehensive SAP Batch Release Hub (BRH) solution roadmap that aligns with the companys longterm 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 crossfunctional 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 & NonSAP Modules:

• Ensure seamless integration between SAP BRH and other SAP modules including SAP S/4HANA SAP SAP PLM QM SAP EWM SAP PP and thirdparty systems ensuring endtoend 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 nontechnical 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 highperforming 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 uptodate 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:

• Bachelors Degree and 8 Years Experience

OR

• Masters 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

Preferred Qualifications:

• Proven experience in SAP solution architecture S/4 HANA BTP (Business Technology Platform) and leadership roles including overseeing endtoend 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) & NonSAP 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.

• Masters 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.

• Handson 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 SAPs batch management lot traceability and quality control features.

• Strong project management skills with experience leading crossfunctional 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 problemsolving 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 fastpaced environment and manage multiple projects simultaneously.

• Strong team player with a collaborative mindset.

For additional benefits information visit:

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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance.

For more information about equal employment opportunity protections please view theKnow Your Rights poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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.