Director, Supply Chain - Risk, Compliance & Traceability
BioSpace, Topeka, KS, United States
Overview
The Director, Risk, Compliance & Traceability at BioMarin reports to the Supply Chain Strategy organization and is responsible for developing, implementing, and managing programs that ensure product integrity, traceability, and compliance across the end‑to‑end supply chain. The Director will drive 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).
Responsibilities
Provide strategic direction for risk, compliance, and traceability across the global supply chain.
Develop and lead a holistic risk management framework that integrates 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 such as 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 align risk, compliance, and traceability processes as the 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.
Attributes
Firm commitment to BioMarin’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.
High level of accountability and ability to act as a change agent in a highly regulated industry.
Flexibility and ability to deal with changing priorities without losing sight of overall business.
Strong interpersonal, communication, and influencing skills working with all levels and within an environment of constant change.
Proactive and energetic outlook with an unwillingness to accept the status quo.
Interaction and collaboration with team members, peers, and senior management.
Ability to work independently with strong time‑management skills.
Education
Bachelor’s or Master’s degree in Engineering, Supply Chain, Life Sciences, or a related field.
Experience
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.
Previous experience leading a global team.
Thorough understanding of technology tools, cold chain related systems, ERP systems, and implementation of scalable compliance solutions.
Strong analytical and organizational skills with the ability to anticipate problems and take proactive action.
Proven ability to lead change initiatives and drive improvements across functions, enabling compliance and mitigating risk.
Ability to work autonomously and independently.
Preferred Qualifications
Experience with biologics, vaccines, or advanced therapies.
Familiarity with digital monitoring systems and data analytics in cold chain.
Lean Six Sigma or a similar process improvement certification.
Equal Opportunity Employer BioMarin is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Responsibilities
Provide strategic direction for risk, compliance, and traceability across the global supply chain.
Develop and lead a holistic risk management framework that integrates 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 such as 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 align risk, compliance, and traceability processes as the 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.
Attributes
Firm commitment to BioMarin’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.
High level of accountability and ability to act as a change agent in a highly regulated industry.
Flexibility and ability to deal with changing priorities without losing sight of overall business.
Strong interpersonal, communication, and influencing skills working with all levels and within an environment of constant change.
Proactive and energetic outlook with an unwillingness to accept the status quo.
Interaction and collaboration with team members, peers, and senior management.
Ability to work independently with strong time‑management skills.
Education
Bachelor’s or Master’s degree in Engineering, Supply Chain, Life Sciences, or a related field.
Experience
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.
Previous experience leading a global team.
Thorough understanding of technology tools, cold chain related systems, ERP systems, and implementation of scalable compliance solutions.
Strong analytical and organizational skills with the ability to anticipate problems and take proactive action.
Proven ability to lead change initiatives and drive improvements across functions, enabling compliance and mitigating risk.
Ability to work autonomously and independently.
Preferred Qualifications
Experience with biologics, vaccines, or advanced therapies.
Familiarity with digital monitoring systems and data analytics in cold chain.
Lean Six Sigma or a similar process improvement certification.
Equal Opportunity Employer BioMarin is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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