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Director, Cold Chain Management & GDP Compliance

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BioMarin Pharmaceutical

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Location:
United States

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Category:
Logistics

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Contract Type:
Not provided

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Salary:

169300.00 - 253900.00 USD / Year
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Job Description:

The Director, Cold Chain Management & Supply Chain GDP is a key role as part of the Global Distribution organization. This role is critical to ensuring the integrity of temperature-sensitive pharmaceutical products throughout the supply chain, while maintaining full compliance with Good Distribution Practice (GDP) regulations and internal quality standards. The incumbent will lead the Global Distribution Center of Excellence for cold chain engineering and Good Distribution Practices supporting distribution (storage and shipping) of all clinical and commercial materials in BioMarin.

Job Responsibility:

  • Lead the design, qualification, and continuous improvement of cold chain systems and packaging solutions for temperature-sensitive products
  • Oversee monitoring of temperature-controlled logistics, including refrigerated transport, passive packaging, and storage facilities
  • Collaborate with internal and external stakeholders to ensure robust cold chain solutions across global markets
  • Drive innovation in cold chain technologies and the streamlined management and quality of associated data
  • Ensure global compliance with GDP regulations and internal quality standards across all distribution channels
  • Develop and maintain policies, procedures, and training programs related to GDP and supply chain integrity
  • Primary point of contact in Supply Chain for audits and inspections related to distribution and cold chain operations
  • Partner with Quality, Regulatory, and Logistics teams to proactively identify and mitigate compliance risks and bridge operational gaps
  • Direct management of a team of individual contributors across global regions
  • Provide strategic direction and leadership to cross-functional teams involved in cold chain and compliance activities
  • Advise senior leadership on investment decisions and emerging trends, providing timely risk insights and strategic recommendations that support informed decision-making

Requirements:

  • Bachelor’s or Master’s degree in Engineering, Supply Chain, Life Sciences, or related field
  • 10+ years of experience in pharmaceutical supply chain, with significant expertise in 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 global trade compliance
  • 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
  • Circa 15% travel

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

Additional Information:

Job Posted:
December 06, 2025

Employment Type:
Fulltime
Work Type:
Remote work
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