Director, Supply Chain - Risk, Compliance & Traceability

Who We Are

Bio Marin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science.

With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well‑understood biology and provide an opportunity to be first‑to‑market or offer a substantial benefit over existing therapeutic options.

Bio Marin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain Bio Marin's cutting‑edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Job Title:

Director, Supply Chain – Risk, Compliance & Traceability

Reports to:

Head Supply Chain Strategy & Excellence

Location:

Remote, US

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.