Senior Manager, Global Logistics Compliance

Overview

• Lead logistics compliance for global pharmaceutical distribution, ensuring adherence to GxP standards and optimizing supply chain processes.
• Collaborate with internal and external partners to manage logistics for drug substances, products, and finished goods.
• Develop and revise SOPs, work instructions, and quality documentation for logistics operations.
• Support audits and inspections by providing documentation and process insights.
• Monitor and maintain GxP compliance across third-party logistics providers and external partners.
• Implement process improvements to enhance logistics compliance and operational efficiency.
• Manage change control activities within Veeva QMS, ensuring timely execution and accurate documentation.
• Support training initiatives related to logistics compliance and Veeva QMS usage.
• Work remotely with occasional travel to offices or other locations as needed.

Key Responsibilities & Duties

• Lead logistics-related change control activities, including authoring, assessing, and managing change actions.
• Oversee global logistics deviations, CAPAs, and quality issues, ensuring compliance with regulations.
• Collaborate with SMEs, QA, Supply Chain, Manufacturing, and Regulatory Affairs for accurate documentation.
• Maintain records of change controls, impact assessments, and effectiveness checks in Veeva QMS.
• Identify gaps and opportunities for process improvement in logistics compliance.
• Support audits and inspections by providing documentation and process insights.
• Develop and revise SOPs, work instructions, and quality documentation related to logistics.
• Monitor GxP compliance across third-party logistics providers and external partners.
• Support training initiatives related to change control and Veeva QMS usage.

Job Requirements

• Bachelor’s degree in Supply Chain, Life Sciences, Engineering, or related field.
• 7+ years of experience in logistics, supply chain, or quality compliance within the pharmaceutical or biotech industry.
• Strong expertise in Veeva QMS, especially in managing change control workflows.
• Deep understanding of GxP, GDP, and GMP regulations.
• Experience working with external manufacturing and logistics partners in a global environment.
• Excellent leadership, communication, and project management skills.
• Experience in rare disease or small-batch pharmaceutical manufacturing (preferred).
• Familiarity with regulatory filing impacts and country-specific logistics requirements.
• Ability to manage multiple concurrent change control records and drive cross-functional alignment.