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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 BioMarin’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).
Job Responsibility:
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
Requirements:
Bachelor’s or Master’s degree in Engineering, Supply Chain, Life Sciences, or related field
Minimum 10-12 years of experience in pharmaceutical supply chain, with significant expertise in risk, security, traceability, cold chain and GDP compliance
Proven leadership experience in a global, matrixed organization
Strong knowledge of regulatory requirements (EU GDP, FDA, WHO, etc.)
Excellent communication, stakeholder management, and problem-solving skills
Bachelor’s degree in related curriculum with a minimum of 10-12 years of experience in Cold Chain, Traceability and Risk Management
Previous experience leading a global team
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)
Strong analytical and organizational skills with the ability to anticipate problems and take proactive actions
Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk
Ability to effectively work autonomously and independently
Nice to have:
Experience with biologics, vaccines, or advanced therapies
Familiarity with digital monitoring systems and data analytics in cold chain
Lean Six Sigma or similar process improvement certification
What we offer:
Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans