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Gilead Sciences

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, San Francisco

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Overview

Sr Manager, IT Business Analysis - SAP BRH Architect role at Gilead Sciences. At Gilead, we’re creating a healthier world for all people. We’re seeking an experienced SAP Batch Release Hub (BRH) Architect with a strong background in Life Sciences to lead the design and implementation of SAP BRH 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.

Responsibilities

  • 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 company’s long-term 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 SAP BRH processes 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 QM, PLM, EWM, 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 BRH and related solutions comply with 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 direction, coaching, and mentorship.
  • Conduct regular performance evaluations and provide feedback to team members.
  • Foster a culture of continuous learning and professional development; promote teamwork and 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 with 8+ years of experience in SAP QM (Quality Management) or related field, preferably in Biotech/Pharmaceutical industry
  • Or Master’s Degree with 6+ years of experience in SAP QM
  • Or PhD with 8+ years of experience in SAP QM or related area

Preferred Qualifications

  • Proven experience in SAP solution architecture S/4HANA, 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) and 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/4HANA 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).
  • 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 batch management, lot traceability, and quality control features.
  • Strong project management skills, with experience leading cross-functional 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, FDA regulations, 21 CFR Part 11, and other relevant industry standards.
  • 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.

Salary & Benefits

Salary Range: Bay Area: $169,320 - $219,120; Raleigh: $146,200 - $189,200. Compensation will vary by experience, qualifications, and location. This role may be eligible for discretionary annual bonus, stock-based incentives, paid time off, and benefits. Benefits include medical, dental, vision, and life insurance plans.

For additional benefits information, visit

Gilead is an equal opportunity employer. Employment decisions will be made without discrimination based on protected characteristics. For accommodation requests, contact

For Current Gilead Employees And Contractors, please apply via the Internal Career Opportunities portal in Workday.

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