Roche logo

Global Supply Chain Process Architect – Planning & Regulatory Compliance

Roche

Risch-Rotkreuz, Zug, Switzerland; Indianapolis, INOnsitePosted 25 days ago
Full TimeSenior LevelOperations & Supply ChainPharmaceutical
Original posting ↗

Summary

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).

Job description

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.

2. 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.

3. 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.

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

Company overview

Roche is a Swiss multinational healthcare company and a global pioneer in pharmaceuticals and diagnostics, founded in 1896 and headquartered in Basel, Switzerland. As the world's largest biotech company and the fifth-largest pharmaceutical company by revenue, Roche operates through two primary divisions: Pharmaceuticals and Diagnostics. The company is renowned for its leadership in personalized healthcare, combining strengths in both drug development and diagnostic testing to deliver tailored treatments for patients. Roche maintains a strong focus on oncology, immunology, infectious diseases, ophthalmology, and central nervous system disorders, with a portfolio that includes over 30 medicines on the World Health Organization's Model Lists of Essential Medicines. The company owns significant subsidiaries including Genentech, Chugai Pharmaceuticals, Ventana Medical Systems, and Foundation Medicine. With approximately 103,000 employees worldwide and operations in over 100 countries, Roche has established itself as a leader in cancer treatments globally while maintaining a robust pipeline of innovative therapies and diagnostic solutions. The company's commitment to sustainability has been recognized through ten consecutive years as Group Leader in the Dow Jones Sustainability Indices within the Pharmaceuticals, Biotechnology & Life Sciences Industry.

Explore more jobs of your matchFind more biopharma roles with GetBioJob.