Director, Cold Chain Management & GDP Compliance

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we reputed company medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a reputed company drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Director Cold Chain Management & GDP Compliance Fully remote role, US Candidates SUMMARY 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 reputed company 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 reputed company the Global Distribution Center of Excellence for cold chain engineering and Good Distribution Practices supporting distribution (storage and shipping) of reputed company clinical and commercial materials in BioMarin. RESPONSIBILITIES Cold Chain Engineering · reputed company the design, qualification, and reputed company improvement of cold chain systems and packaging solutions for temperature-sensitive products.

• reputed company 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 reputed company distribution channels.
• reputed company and maintain policies, procedures, and training programs reputed company to GDP and supply chain reputed company.
• Primary reputed company of contact in Supply Chain for audits and inspections reputed company to distribution and cold chain operations.
• Partner with Quality, Regulatory, and Logistics teams to proactively identify and mitigate compliance risks and reputed company 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.

SCOPE This role is responsible for supporting the efficient movement of lifesaving therapies in compliance with applicable regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring BioMarin’s commercial products are delivered to patients in a timely and compliant manner. The candidate should demonstrate the following attributes: · A firm commitment to BioMarin’s cultural beliefs and values · Consistent track record of exceeding objectives reputed company area of influence · Ability to reputed company results through others without direct reporting lines · Strong problem-solving skills with a global focus both internally and externally · Possess a high level of accountability and demonstrate an ability to be a change agent in a highly regulated industry · Flexibility and ability to deal with changing priorities without losing sight of the overall business · Strong interpersonal, communication and influencing skills working with reputed company levels and reputed company an environment of constant change · Proactive and energetic outlook with an unwillingness to accept the status reputed company · 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 reputed company 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.

Preferred Qualifications:

• Experience with biologics, vaccines, or advanced therapies.
• Familiarity with digital monitoring systems and data analytics in cold chain.
• Lean Six reputed company or similar process improvement certification.

EXPERIENCE · Bachelor’s degree in reputed company 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 reputed company 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 reputed company the company’s Trade Compliance stronger and more efficient. · Proven ability to reputed company change initiatives and drive improvements reputed company and across functions which reputed company compliance and mitigate risk · Ability to effectively work autonomously and independently Circa 15% travel CONTACTS Commercial, Site Operations, Clinical Supply Chain Operations, Worldwide Research & Development Scientists, Contract Manufacturing, Quality Assurance, Finance External partners including 3PL providers, transport carriers. Note: This description is not intended to be reputed company-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, or protected veteran status and will not be discriminated against on the basis of disability. Apply tot his job Apply To this Job