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Director, Cold Chain Management & GDP Compliance Jobs

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Director, Cold Chain Management & GDP Compliance
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Lead global cold chain engineering and GDP compliance for temperature-sensitive pharmaceuticals. This director role requires 10+ years in pharma supply chain, expertise in EU/FDA regulations, and proven leadership. You will design robust systems, ensure compliance, and drive innovation across glo...
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United States
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Salary
169300.00 - 253900.00 USD / Year
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BioMarin Pharmaceutical
Expiration Date
Until further notice
Pursue leadership roles where science meets strategy by exploring Director of Cold Chain Management & GDP Compliance jobs. This senior executive position sits at the critical nexus of pharmaceutical supply chain integrity, regulatory compliance, and patient safety. Professionals in this field are the ultimate guardians of temperature-sensitive medicinal products, from biologic therapies and vaccines to advanced cell and gene therapies. Their core mission is to ensure these life-saving products maintain their safety, efficacy, and quality from the moment they leave the manufacturing site until they reach the end patient, anywhere in the world. This is not merely a logistics role; it is a strategic, quality-focused leadership function essential for global health. A Director in this domain typically oversees the entire cold chain ecosystem. This involves providing strategic direction for the design, qualification, and continuous improvement of temperature-controlled packaging solutions and storage infrastructure. They establish and enforce global standards for shipping, handling, and monitoring products across refrigerated, frozen, and controlled room temperature ranges. A paramount and parallel responsibility is ensuring unwavering compliance with Good Distribution Practice (GDP) regulations across all territories. This includes interpreting complex guidelines from agencies like the FDA, EMA, and WHO, and translating them into actionable, audit-ready policies and procedures for the entire distribution network. The role serves as the primary point of contact for regulatory inspections and customer audits related to distribution practices. On a day-to-day basis, common responsibilities include leading a team of specialists and a cross-functional network. Directors develop risk management strategies, oversee temperature excursion investigations, and drive innovation in cold chain technologies and data management systems. They collaborate closely with Quality Assurance, Regulatory Affairs, Logistics, and Commercial teams to bridge gaps and proactively mitigate supply chain risks. Furthermore, they are responsible for crafting and delivering comprehensive training programs to instill a culture of quality and compliance throughout the organization. Their analytical insights and strategic recommendations directly influence senior leadership decisions on capital investments and global supply chain strategy. Typical requirements for these high-level jobs include an advanced degree in Engineering, Life Sciences, Pharmacy, or Supply Chain Management, coupled with 10+ years of progressive experience in pharmaceutical operations. Candidates must possess deep, hands-on expertise in cold chain engineering and a thorough mastery of global GDP regulations. Essential skills extend beyond technical knowledge to include proven leadership in a matrixed environment, exceptional stakeholder management, and sophisticated problem-solving abilities. Success demands a strategic mindset, a relentless focus on quality, and the ability to drive change, making these directors indispensable in the secure and compliant delivery of modern medicines.

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