BioMarin Pharmaceutical Inc.
SAP Business Analyst Lead - Plan to Produce Workstream
BioMarin Pharmaceutical Inc., San Rafael, California, United States, 94911
Overview
We are seeking an experienced SAP Business Analyst Lead to spearhead the Plan to Produce workstream, focusing on Manufacturing (In-house and Contract), Quality Control, and Quality Assurance within a GxP-regulated environment. The lead will drive the integration of processes across critical subsystems, including SAP, Laboratory Information Management Systems (LIMS), Warehouse Management Systems (WMS), Manufacturing Execution Systems (MES), and Quality Management Systems (QMS), to ensure seamless operations, compliance, and efficiency. Key Responsibilities
Process Leadership & Integration
Lead the design, configuration, and implementation of SAP modules (e.g., PP, QM, MM) to support end-to-end Plan to Produce processes, including production planning, shop floor execution, quality management, and material management. Facilitate integration between SAP and subsystems (LIMS, WMS, MES, QMS) to ensure data consistency, process alignment, and real-time visibility across manufacturing and quality operations. Collaborate with cross-functional teams to map and optimize business processes, ensuring compliance with GxP standards and regulatory requirements (e.g., FDA, EMA).
Manufacturing Support
Support both in-house and contract manufacturing operations by configuring SAP solutions to manage production schedules, capacity planning, and material traceability. Ensure SAP configurations align with manufacturing workflows, including batch management, shop floor control, and contract manufacturing processes.
Quality Control & Assurance
Oversee the implementation of SAP Quality Management (QM) module to support quality control and assurance processes in a GxP environment. Enable integration with QMS for non-conformance management, CAPA (Corrective and Preventive Actions), and audit trails. Ensure traceability and compliance for quality-related data across SAP, LIMS, and QMS systems.
Stakeholder Collaboration
Act as the primary liaison between business units (Manufacturing, Quality, Supply Chain) and IT teams to translate business requirements into technical specifications. Lead workshops, cross-functional collaboration, requirement-gathering sessions, and solution design reviews to align stakeholders on process improvements and system capabilities.
Project Management & Delivery
Drive end-to-end project execution, including requirements analysis, solution design, testing, training, and go-live support for SAP and integrated subsystems. Develop and maintain project documentation, including business process flows, functional specifications, and test scripts. Ensure timely delivery of projects while adhering to budget, scope, and quality standards.
Continuous Improvement
Identify opportunities for process optimization and system enhancements to improve operational efficiency and compliance. Stay updated on SAP advancements, industry best practices, and GxP regulations to recommend innovative solutions.
Qualifications
Bachelor's degree in Business, Information Technology, Engineering, or a related field; advanced degree preferred. 7+ years of experience as an SAP Business Analyst, with at least 3 years in a lead role supporting Plan to Produce processes. Expertise in SAP modules such as PP (Production Planning), QM (Quality Management), and MM (Materials Management); experience with SAP S/4HANA is a plus. Proven experience integrating SAP with LIMS, WMS, MES, and QMS in a manufacturing or life sciences environment. Strong understanding of GxP regulations (e.g., 21 CFR Part 11, GMP) and their application to manufacturing and quality processes. Experience with in-house and contract manufacturing workflows, including batch management and material traceability. Excellent project management skills, with proficiency in tools like MS Project, Jira, or similar. Strong analytical, problem-solving, and communication skills to bridge business and technical teams. SAP certifications (e.g., SAP PP, QM, or S/4HANA) are highly desirable. Preferred Skills
Knowledge of Industry 4.0 technologies, such as IoT or automation, in manufacturing environments. Familiarity with data analytics and reporting tools (e.g., SAP Analytics Cloud, Data Sphere Power BI) for process insights. Experience with Agile or DevOps methodologies for system implementation. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The salary range for this position is: $134,400 to $184,000. BioMarin 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://careers.biomarin.com/benefits. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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We are seeking an experienced SAP Business Analyst Lead to spearhead the Plan to Produce workstream, focusing on Manufacturing (In-house and Contract), Quality Control, and Quality Assurance within a GxP-regulated environment. The lead will drive the integration of processes across critical subsystems, including SAP, Laboratory Information Management Systems (LIMS), Warehouse Management Systems (WMS), Manufacturing Execution Systems (MES), and Quality Management Systems (QMS), to ensure seamless operations, compliance, and efficiency. Key Responsibilities
Process Leadership & Integration
Lead the design, configuration, and implementation of SAP modules (e.g., PP, QM, MM) to support end-to-end Plan to Produce processes, including production planning, shop floor execution, quality management, and material management. Facilitate integration between SAP and subsystems (LIMS, WMS, MES, QMS) to ensure data consistency, process alignment, and real-time visibility across manufacturing and quality operations. Collaborate with cross-functional teams to map and optimize business processes, ensuring compliance with GxP standards and regulatory requirements (e.g., FDA, EMA).
Manufacturing Support
Support both in-house and contract manufacturing operations by configuring SAP solutions to manage production schedules, capacity planning, and material traceability. Ensure SAP configurations align with manufacturing workflows, including batch management, shop floor control, and contract manufacturing processes.
Quality Control & Assurance
Oversee the implementation of SAP Quality Management (QM) module to support quality control and assurance processes in a GxP environment. Enable integration with QMS for non-conformance management, CAPA (Corrective and Preventive Actions), and audit trails. Ensure traceability and compliance for quality-related data across SAP, LIMS, and QMS systems.
Stakeholder Collaboration
Act as the primary liaison between business units (Manufacturing, Quality, Supply Chain) and IT teams to translate business requirements into technical specifications. Lead workshops, cross-functional collaboration, requirement-gathering sessions, and solution design reviews to align stakeholders on process improvements and system capabilities.
Project Management & Delivery
Drive end-to-end project execution, including requirements analysis, solution design, testing, training, and go-live support for SAP and integrated subsystems. Develop and maintain project documentation, including business process flows, functional specifications, and test scripts. Ensure timely delivery of projects while adhering to budget, scope, and quality standards.
Continuous Improvement
Identify opportunities for process optimization and system enhancements to improve operational efficiency and compliance. Stay updated on SAP advancements, industry best practices, and GxP regulations to recommend innovative solutions.
Qualifications
Bachelor's degree in Business, Information Technology, Engineering, or a related field; advanced degree preferred. 7+ years of experience as an SAP Business Analyst, with at least 3 years in a lead role supporting Plan to Produce processes. Expertise in SAP modules such as PP (Production Planning), QM (Quality Management), and MM (Materials Management); experience with SAP S/4HANA is a plus. Proven experience integrating SAP with LIMS, WMS, MES, and QMS in a manufacturing or life sciences environment. Strong understanding of GxP regulations (e.g., 21 CFR Part 11, GMP) and their application to manufacturing and quality processes. Experience with in-house and contract manufacturing workflows, including batch management and material traceability. Excellent project management skills, with proficiency in tools like MS Project, Jira, or similar. Strong analytical, problem-solving, and communication skills to bridge business and technical teams. SAP certifications (e.g., SAP PP, QM, or S/4HANA) are highly desirable. Preferred Skills
Knowledge of Industry 4.0 technologies, such as IoT or automation, in manufacturing environments. Familiarity with data analytics and reporting tools (e.g., SAP Analytics Cloud, Data Sphere Power BI) for process insights. Experience with Agile or DevOps methodologies for system implementation. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The salary range for this position is: $134,400 to $184,000. BioMarin 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://careers.biomarin.com/benefits. Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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