Director, Global Supplier Quality Management

The Director, Global Supplier Quality Management is a senior leadership role with enterprise-wide authority and accountability for the governance, effectiveness, and continuous advancement of Bio Marin’s global Supplier Quality Management framework across the external supply network for GMP/GDP materials. This role serves as the quality authority for suppliers and materials, ensuring sustained regulatory compliance, product quality, and patient safety while enabling uninterrupted and scalable business operations.

The Director defines and drives the global Supplier Quality vision and strategy and exercises decision-making authority across the full supplier lifecycle, in close partnership with Procurement and Technical Operations. This includes supplier qualification, raw material specification oversight, quality agreements, supplier changes, deviations, performance management, auditing, and inspection readiness. The role interfaces at the enterprise level with senior leaders across Quality, Technical Operations, Manufacturing, Legal and Procurement to prevent quality risk, improve supplier capability, and embed a consistent, risk-based approach across the global network.

As a key change leader within Quality, the Director is also accountable for advancing digital and data-enabled Supplier Quality capabilities, including the adoption of automation, advanced analytics, and artificial intelligence (AI). Through these capabilities, the role ensures proactive risk identification, data-driven decision-making, and scalable oversight aligned with Bio Marin’s long-term business and quality strategy. This position requires deep GxP expertise, strong executive presence, and the ability to operate with authority and influence in a complex, global, matrixed organization.

• Establish and maintain a risk-based, fit-for-purpose Global Supplier Quality Management framework aligned with Bio Marin’s Global Quality Management System (QMS) and global regulatory requirements.
• Define and execute the global Supplier Quality strategy to ensure consistent oversight, compliance, inspection readiness, and continuous improvement across the external supply network.
• Jointly with Procurement, hold end-to-end ownership of the Supplier Lifecycle Management program, spanning supplier selection, qualification, onboarding, performance management, change management, and lifecycle exit decisions.
• Own and oversee Supplier Quality core processes, including supplier qualification and lifecycle management, quality agreements, supplier changes, deviations, CAPA, and supplier auditing activities related to external suppliers.
• Develop and maintain governance models, metrics, and management review processes to monitor Supplier Quality performance and elevate compliance risks appropriately.
• Ensure quality oversight of external suppliers, with a primary focus on materials and services supporting Technical Operations.
• Provide Quality oversight for raw material specification management, ensuring specifications are scientifically sound, compliant, and aligned with manufacturing and control strategies.
• Develop, define, and apply risk-based supplier oversight and segmentation models to focus resources on critical suppliers and material risks.
• Establish and manage key Supplier Quality performance indicators, ensuring trending, signal detection, and timely actions.
• Lead supplier quality issue investigations, risk assessments, and mitigation strategies to prevent non-conformances from impacting Bio Marin operations or patients.
• Collaborate with Procurement and Suppliers to drive quality improvement initiatives and enhance supplier capability, robustness, and compliance.
• Establish, manage, and continuously improve the global Supplier Auditing program for all GMP and GDP suppliers, including audit strategy, planning, execution, follow-up, and effectiveness verification.
• Ensure supplier audit outcomes, identified risks, and corrective actions are appropriately evaluated, trended, and integrated into Supplier Lifecycle Management and Quality Management Review processes.
• Support and represent Supplier Quality during regulatory inspections and external audits involving suppliers and the external supply network.
• Lead the digital advancement of Supplier Quality by defining and executing a Supplier Quality technology and data roadmap aligned with the broader Quality Digital Strategy.
• Leverage advanced analytics, automation, and AI-enabled solutions to improve supplier performance monitoring, risk identification, trend analysis, audit effectiveness, and decision-making.
• Drive effective use of Supplier Quality data by integrating information from QMS, ERP, and external systems to generate actionable insights across the supplier lifecycle.
• Partner with IT, Quality Systems, and business stakeholders to implement sustainable, scalable digital and AI solutions that enhance Supplier Quality effectiveness and efficiency.
• Partner closely with Global Procurement, Manufacturing,…