Director, Global Supplier Quality Management

Establish and Maintain

Establish and maintain a risk-based, fit-for-purpose Global Supplier Quality Management framework aligned with BioMarin’s Global Quality Management System (QMS) and global regulatory requirements.

Define and Execute

Define and execute the global Supplier Quality strategy to ensure consistent oversight, compliance, inspection readiness, and continuous improvement across the external supply network.

Supplier Lifecycle Management

• 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.

Core Processes

• Supplier qualification and lifecycle management
• Quality agreements
• Supplier changes
• Deviations
• CAPA
• Supplier auditing activities

Governance Models and Metrics

Develop and maintain governance models, metrics, and management review processes to monitor Supplier Quality performance and escalate compliance risks appropriately.

Quality Oversight

• Quality oversight of external suppliers, with a primary focus on materials and services supporting Technical Operations.
• Quality oversight for raw material specification management.

Risk-Based Oversight

• Develop and apply risk-based supplier oversight and segmentation models to focus resources on critical suppliers and material risks.

Performance Indicators

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.

Issue Investigations and Risk Assessments

• Lead supplier quality issue investigations, risk assessments, and mitigation strategies to prevent non-conformances from impacting BioMarin operations or patients.

Collaboration and Improvement

• Collaborate with Procurement and Suppliers to drive quality improvement initiatives and enhance supplier capability, robustness, and compliance.

Auditing Program

• Establish and manage key Supplier Quality performance indicators, ensuring trending, signal detection, and timely actions.
• Ensure quality oversight of external suppliers, with a primary focus on materials and services supporting Technical Operations.
• Lead supplier quality issue investigations, risk assessments, and mitigation strategies to prevent non-conformances from impacting BioMarin operations or patients.
• Collaborate with Procurement and Suppliers to drive quality improvement initiatives and enhance supplier capability, robustness, and compliance.

Digital Advancement

• 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.

Data Integration and Insights

Drive effective use of Supplier Quality data by integrating information from QMS, ERP, and external systems to generate actionable insights across the supplier lifecycle.

Stakeholder Engagement

• Partner with IT, Quality Systems, and business stakeholders to implement sustainable, scalable digital and AI solutions that enhance Supplier Quality effectiveness and efficiency.

Stakeholder Representation

• Represent Supplier Quality in cross-functional governance forums and during regulatory inspections and audits.

Team Leadership

• Lead, coach, and develop a high-performing global Supplier Quality team across multiple geographies.

Talent Management

• Establish clear roles, responsibilities, capabilities, and succession plans within the Supplier Quality organization.
• Drive a consistent, standardized approach to Supplier Quality and supplier lifecycle governance across the global network while enabling flexibility where required.

Culture and Accountability

• Foster a culture of quality, continuous improvement, innovation, and accountability within the team.

Financial Management

• Drive effective use of Supplier Quality data by integrating information from QMS, ERP, and external systems to generate actionable insights across the supplier lifecycle.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline required.
• Advanced degree (MS, PhD, MBA) desirable but not required.
• Six Sigma or Lean certification desirable.
• Minimum of 15 years of experience in Quality Assurance, Supplier Quality, Manufacturing, or related roles within a highly regulated industry (biotechnology, pharmaceutical, medical device, or combination products).
• In-depth knowledge of global quality and regulatory requirements (e.g., GMP, GCP, GDP, ISO standards, 21 CFR).
• Demonstrated experience leading global supplier quality programs and managing complex external supply networks.
• Proven leadership experience with the ability to develop, mentor, and inspire high-performing teams.
• Strong experience operating in a matrix, global environment and influencing without direct authority.
• Experience leading or sponsoring transformational change, including digital transformation initiatives.
• Demonstrated experience using data, analytics, and digital tools to improve quality outcomes; experience with AI-enabled solutions a strong plus.
• Excellent communication, collaboration, and stakeholder management skills, including interaction with senior leadership and regulators.