Global Supply Chain Process Architect - Planning & Regulatory Compliance

F. Hoffmann-La Roche Ltd
  • Indianapolis, IN
    30+ days ago

    Job Description

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

    The Position

    The Global Supply Chain Process Architect - Planning & Regulatory Compliance serves as the chief process architect for End-to-End (E2E) Supply Chain Planning and Regulatory Compliance. Sitting within the Global Supply Chain Solutions Design organization, this role is responsible for architecting future-state planning processes (S&OP/IBP, Demand, Supply, Production Scheduling, and Inventory Optimization) while ensuring all workflows strictly comply with global healthcare regulations (e.g., GDP, ISO 13485, 21 CFR 820).

    By applying Systems Thinking, this role bridges the gap between commercial demand, R&D/manufacturing constraints, and international regulatory requirements, ensuring that global planning frameworks are efficient, compliant, and resilient.

    Core Responsibilities

    1. Strategic Planning Process Architecture & Governance
    • E2E Planning Process Ownership: Lead the architectural design, standardization, and L1-L3 process mapping for core planning functions, including Sales & Operations Planning (S&OP) / Integrated Business Planning (IBP), Demand Planning, Supply & Capacity Planning, Inventory Optimization, and Order Fulfillment.

    • System Translation: Partner with IT/BPM to translate business planning frameworks into advanced digital systems (e.g., SAP ,OMP), ensuring high data integrity and seamless system interfaces across manufacturing sites and distribution hubs.

    • Delegation of Authority (DoA): Maintain and govern Supply Chain DoA frameworks, ensuring clear decision-making thresholds across demand/supply balancing, inventory write-offs, and allocation rules.

    1. Regulatory Compliance & Risk Mitigation
    • Global SC Regulatory Frameworks: Act as the subject matter expert ensuring all designed planning and execution processes adhere to global regulatory standards (EU GDP/GMP, US FDA 21 CFR 820 / Part 11, China NMPA, ISO 13485/9001).

    • Cold-Chain & Product Lifecycle Rules: Integrate regulatory constraints (e.g., shelf-life limits, cold-chain stability budgets, country-specific registration controls, and import/export quotas) directly into supply planning models.

    • Audit Readiness & Process Integrity: Lead root-cause problem solving (CAPA) for planning or execution failures to prevent recurrence and maintain continuous audit readiness across the global network.

    1. Cross-Functional Collaboration & Innovation
    • Silo-Breaking Alignment: Drive alignment between R&D, Manufacturing, Quality, Regulatory Affairs, and Commercial teams to resolve competing priorities (e.g., balancing launch speed vs. regulatory validation vs. inventory exposure).

    • Continuous Improvement: Apply Lean design and Advanced Analytics to optimize safety stock parameters, reduce plan-to-produce cycle times, and minimize write-offs/scrap.

    • Change Management & Capability Building: Coach regional planning teams on global process standards, fostering a culture of continuous improvement, agility, and proactive risk management.

    Candidate Profile (Who You Are)

    Education & Experience

    • Education: Bachelor's degree in Supply Chain Management, Industrial Engineering, Life Sciences, or a related field. Advanced degree (Master's, MBA, or Ph.D.) highly preferred.

    • Professional Experience: 8+ years of progressive leadership experience in Supply Chain within the Pharmaceutical, Diagnostics, Medical Device, or Biotech industries.

    • Planning Expertise: Demonstrated hands-on track record designing or optimizing global Supply Chain Planning frameworks (S&OP/IBP, Multi-Echelon Inventory Optimization, Supply/Demand Balancing).

    Technical Skills & Regulatory Knowledge

    • Regulatory Mastery: Deep, working knowledge of international healthcare supply chain regulations, GDP/GMP standards, and country-specific trade compliance rules (EU, US FDA, China NMPA).

    • Systems & Digital Literacy: Solid understanding of enterprise planning architectures (e.g., SAP IBP, S/4HANA) and how business planning requirements translate into technical solution design.

    • Methodologies: Strong proficiency in Lean/Six Sigma principles, Systems Thinking, and advanced process-mapping standards .

    Leadership & Competencies

    • Enterprise Mindset: Ability to navigate high-ambiguity matrix environments, resolve cross-functional friction, and represent Global Supply Chain to senior business leaders.

    • Transformational Leadership: Passionate about talent development, transparent communication, and driving organizational change while upholding corporate values of Integrity, Courage, and Passion.

    Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

    Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Rotkreuz. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

    Who we are

    A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

    Let's build a healthier future, together.

    Roche is an Equal Opportunity Employer.

    Numbers & Facts

    LocationIndianapolis, IN

    Skills

    • Architectural Designunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Budgetingunmatched
    • Business Administrationunmatched
    • Business Planunmatched
    • Business Process Managementunmatched
    • Capacity Managementunmatched
    • Change Managementunmatched
    • Coachingunmatched
    • Code of Federal Regulationsunmatched
    • Continuous Improvementunmatched
    • Corrective and Preventative Action (CAPA) Systemsunmatched
    • Cross-Functionalunmatched
    • Data Qualityunmatched
    • Demand Forecasting/Planningunmatched
    • Diseaseunmatched
    • Distribution Servicesunmatched
    • Enterprise Architectureunmatched
    • FDA (Food and Drug Administration)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Healthcareunmatched
    • Hubsunmatched
    • ISO (International Organization for Standardization)unmatched
    • ISO 9001unmatched
    • Import/Exportunmatched
    • Industrial Engineeringunmatched
    • International Healthunmatched
    • Inventory Estimatesunmatched
    • Inventory Planningunmatched
    • Leadershipunmatched
    • Lean Manufacturingunmatched
    • Lean Six Sigmaunmatched
    • Literacyunmatched
    • Manufacturingunmatched
    • Manufacturing Systemsunmatched
    • Medical Diagnosisunmatched
    • Medical Equipmentunmatched
    • Medical Productsunmatched
    • Operations Planningunmatched
    • Order/Customer Fulfillmentunmatched
    • Problem Solving Skillsunmatched
    • Process Improvementunmatched
    • Product Lifecycleunmatched
    • Production Scheduleunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Research & Development (R&D)unmatched
    • Risk Managementunmatched
    • SAPunmatched
    • Sales & Operations Process (S&OP)unmatched
    • Sales Operationsunmatched
    • Strategic Planningunmatched
    • Supplier Optimizationunmatched
    • Supply Chainunmatched
    • Supply Chain Managementunmatched
    • Supply Chain Optimizationunmatched
    • Talent Managementunmatched
    • Technical/Engineering Designunmatched
    • Urban Planningunmatched

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