Global Supply Chain Process Architect – Planning & Regulatory Compliance

Roche•Indianapolis, IN

10h•Remote

About 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.

Requirements

Bachelor’s degree in Supply Chain Management, Industrial Engineering, Life Sciences, or a related field.
8+ years of progressive leadership experience in Supply Chain within the Pharmaceutical, Diagnostics, Medical Device, or Biotech industries.
Demonstrated hands-on track record designing or optimizing global Supply Chain Planning frameworks (S&OP/IBP, Multi-Echelon Inventory Optimization, Supply/Demand Balancing).
Deep, working knowledge of international healthcare supply chain regulations, GDP/GMP standards, and country-specific trade compliance rules (EU, US FDA, China NMPA).
Solid understanding of enterprise planning architectures (e.g., SAP IBP, S/4HANA) and how business planning requirements translate into technical solution design.
Strong proficiency in Lean/Six Sigma principles, Systems Thinking, and advanced process-mapping standards.
Ability to navigate high-ambiguity matrix environments, resolve cross-functional friction, and represent Global Supply Chain to senior business leaders.
Passionate about talent development, transparent communication, and driving organizational change while upholding corporate values of Integrity, Courage, and Passion.

Nice To Haves

Advanced degree (Master’s, MBA, or Ph.D.) highly preferred.

Responsibilities

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.
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.
Maintain and govern Supply Chain Delegation of Authority (DoA) frameworks, ensuring clear decision-making thresholds across demand/supply balancing, inventory write-offs, and allocation rules.
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).
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.
Lead root-cause problem solving (CAPA) for planning or execution failures to prevent recurrence and maintain continuous audit readiness across the global network.
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).
Apply Lean design and Advanced Analytics to optimize safety stock parameters, reduce plan-to-produce cycle times, and minimize write-offs/scrap.
Coach regional planning teams on global process standards, fostering a culture of continuous improvement, agility, and proactive risk management.