Associate Director, Solutions Architect

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BioMarin Pharmaceutical Inc.

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1001 - 5000 employés

Fondée en 1997

🧬 Biotechnologie

💊 Pharmaceutique

💰 Post-IPO Debt en 2020-05

Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. est une entreprise de biotechnologie mondiale de premier plan, dédiée à transformer les découvertes génétiques en médicaments innovants. Fondée en 1997, l'entreprise a développé huit produits commercialisés qui traitent des maladies génétiques et des troubles du stockage lysosomal mettant en jeu le pronostic vital, tels que l'achondroplasie et l'hémophilie A sévère. BioMarin investit fortement dans la recherche et le développement, avec un pipeline robuste de médicaments expérimentaux à divers stades d'essais cliniques. La mission de l'entreprise tourne autour de l'amélioration des soins aux patients en utilisant une expertise scientifique pour comprendre les causes sous-jacentes de ces conditions. BioMarin s'engage à l'inclusivité et à la défense des patients, en travaillant étroitement avec les communautés pour améliorer les soins et la qualité de vie des personnes atteintes de maladies rares.

Description

• Responsible for designing, describing, and managing SAP solution design of SAP modules (e.g., PP, QM, MM) to support end-to-end Plan to Deliver processes, including production planning, shop floor execution, quality management, and material management. • Facilitate integration between SAP and boundary applications (LIMS, WMS, MES, QMS) to ensure data consistency, process alignment, and real-time visibility across manufacturing, quality operations, and warehouse processes. • Collaborate with cross-functional teams and business stakeholders to map and optimize business processes, ensuring compliance with GxP standards and regulatory requirements (e.g., FDA, EMA) and upholding “fit to standard” design principles in alignment with organizational goals. • Develop and maintain functional specifications, process flows, integration plans and system configurations to ensure PTD processes scalability, reliability, and performance. • Review configurations and deployments to maintain quality standards. • Create clear, concise decision rationale documents balancing innovation with practicality, considering factors like cost, support, and compatibility with global end to end designs. • Effectively communicate complex technical concepts to non-technical stakeholders and multifaceted business processes to technical stakeholders. • 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. • 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. • Act as the primary liaison between business units (Manufacturing, Quality, Supply Chain) and IT teams to translate business requirements into technical specifications. • Facilitate workshops, Cross functional Collaboration, requirement-gathering sessions, and solution design reviews to align stakeholders on process improvements and system capabilities. • Guide cross-functional teams (e.g., SAP technical consultants, integration specialists, and business users) to deliver PTD solutions. • 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. • 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. • Act as strategic connector between business goals and technical execution to identify and recommend PTD solution improvements through post-implementation monitoring.

🎯 Exigences

• 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, EWM or S/4HANA) are highly desirable.

🏖️ Avantages

• Equal Opportunity Employer/Veterans/Disabled