Director, Supply Chain - Risk, Compliance & Traceability

Role Summary

The Director, Supply Chain - Risk, Compliance & Traceability will develop, implement and manage programs to ensure product integrity, traceability, and regulatory compliance across Bio Marin’s end-to-end supply chain. The role leads strategic initiatives in serialization, cold chain compliance, and risk management, collaborating across functions to ensure compliant and efficient distribution of Bio Marin’s products. It also oversees cold chain technology and innovation to influence product design and ensure temperature-sensitive products are distributed in full GDP compliance.

Location:

Remote, US.

• 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 risk, compliance and traceability processes; partner 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.

• Required: Minimum 10–12 years of experience in pharmaceutical supply chain, with significant expertise in risk, security, traceability, cold chain and GDP compliance.
• Required: Proven leadership experience in a global, matrixed organization.
• Required: Strong knowledge of regulatory requirements (EU GDP, FDA, WHO, etc.).
• Required: Excellent communication, stakeholder management, and problem-solving skills.
• Required: Previous experience leading a global team.
• Required: Thorough understanding of technology tools, cold chain related systems and ERP systems, with a proven record of implementing scalable compliance solutions (systems, procedures, and processes).
• Required: Ability to work autonomously and independently.
• Required: Strong analytical and organizational skills with the ability to anticipate problems and take proactive actions to strengthen trade compliance.
• Preferred: Experience with biologics, vaccines, or advanced therapies.
• Preferred: Familiarity with digital monitoring systems and data analytics in cold chain.
• Preferred: Lean Six Sigma or similar process improvement certification.

• Strategic leadership and risk management across global supply chains
• Cross-functional collaboration and vendor management
• Audits, regulatory inspections, and internal controls
• Serialization and product traceability design and implementation
• Digital control towers and data integration for end-to-end visibility
• Emerging technologies evaluation (e.g., blockchain) to enhance transparency
• GDP/compliance knowledge and regulatory understanding
• Change management, continuous improvement, and problem-solving
• Strong communication, stakeholder management, and influence

• Bachelor’s or Master’s degree in Engineering, Supply Chain, Life Sciences, or related field.

• Travel:
  Approximately 15% travel.
• Physical Demands:
  Sit and talk or hear; occasional standing, walking, and use of hands; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl; occasional lifting up to 25 pounds; vision requirements (close vision, depth perception, and ability to adjust focus).