Director, Supply Chain - Risk, Compliance & Traceability

The Director, Risk, Compliance & Traceability reporting to the Supply Chain Strategy organization will be responsible for developing, implementing and managing programs that ensure product integrity, traceability, and compliance across the end-to-end supply chain. The Director drives key initiatives involving serialization, cold chain compliance, and risk management, partnering across functions to ensure compliant and efficient distribution of Bio Marin’s products. This position also oversees cold chain technology and innovation, influencing product design and ensuring temperature-sensitive products are distributed in full compliance with Good Distribution Practice (GDP).

• Provide strategic direction for risk, compliance, and traceability across the global supply chain.
• Develop and lead a holistic risk management framework integrating geopolitical, operational, compliance, and cybersecurity risks.
• Lead risk maturity assessments, stress testing, and the deployment of predictive analytics and AI/ML tools for early warning and real‑time monitoring.
• Advise executive leadership on emerging trends, risk metrics, and strategic recommendations.

• Oversee the design, qualification, and continuous improvement of cold chain systems and packaging for temperature‑sensitive products.
• Drive innovation in cold chain technologies, including advanced monitoring systems, digital data analytics, and next‑generation packaging solutions.
• Ensure global compliance with GDP and other regulatory requirements (EU GDP, FDA, WHO, DSCSA, EU FMD, ANVISA, etc.).
• Develop and maintain policies, procedures, and training programs related to GDP, compliance, and supply chain integrity.
• Serve as the primary point of contact for audits and inspections related to cold chain, and traceability.

• Lead the design, implementation, and continuous improvement of serialization and traceability programs.
• Build and manage a digital control tower for end‑to‑end product traceability, integrating data from manufacturing, packaging, logistics, and distribution.
• Evaluate and implement emerging technologies like blockchain to enhance transparency and trust.
• Develop and oversee a comprehensive product security framework to detect, deter, and respond to threats such as counterfeiting, diversion, and tampering.

• Collaborate with Global Supply Chain functions to ensure alignment on the required risk, compliance and traceability processes as main client of the role.
• Collaborate with Quality, Regulatory, IT, Legal, Commercial, Clinical Supply Chain and Logistics teams to align initiatives with business goals.
• Manage relationships with solution providers, technology vendors, and third‑party logistics partners.

• Directly manage and develop a global team, focusing on talent development and program continuity.
• Provide leadership to cross‑functional teams and foster a culture of accountability, innovation, and continuous improvement.

This role is responsible for supporting the efficient movement of lifesaving therapies in compliance with applicable regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring Bio Marin’s commercial products are delivered to patients in a compliant and timely manner.

The candidate should demonstrate the following attributes:

• A firm commitment to Bio Marin’s cultural beliefs and values.
• Consistent track record of exceeding objectives within area of influence.
• Ability to achieve results through others without direct reporting lines.
• Strong problem‑solving skills with a global focus both internally and externally.
• Possess a high level of accountability and demonstrate an ability to be a change agent in a highly regulated industry.
• Flexibility and ability to deal with changing priorities without losing sight of the overall business.
• Strong interpersonal, communication and influencing skills working with all levels and within an environment of constant change.
• Proactive and energetic…