Director, Cold Chain Management & GDP Compliance Jobs

BioMarin Pharmaceutical

Location:
United States

Category:
Logistics

Contract Type:
Not provided

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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Director, Cold Chain Management & GDP Compliance