Director, Cold Chain Management & GDP Compliance

Role Summary

The Director, Cold Chain Management & GDP Compliance leads the Global Distribution Center of Excellence for cold chain engineering and Good Distribution Practices, ensuring the integrity of temperature-sensitive pharmaceutical products across the supply chain while maintaining full GDP compliance and internal quality standards. This role directs global cold chain design, qualification, and compliance efforts, supporting distribution of all clinical and commercial materials.

Responsibilities

• Cold Chain Engineering
• 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.

• Supply Chain Compliance & GDP
• 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.

• Leadership & Strategy
• 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.

Education

• Bachelor‚Äôs or Master‚Äôs 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.

Experience

• Bachelor‚Äôs 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 to make the company‚Äôs Trade Compliance stronger and more efficient.
• 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

Skills

• Cold chain engineering and packaging design
• GDP compliance and regulatory knowledge (EU GDP, FDA, WHO)
• Audits, inspections, and quality systems
• Cross-functional leadership and stakeholder management
• Data analytics and digital monitoring systems (preferred)

Additional Requirements

• Circa 15% travel