Senior Manager, Global Logistics Compliance

Overview

• Drive global logistics compliance for pharmaceutical distribution, ensuring adherence to GxP standards and optimizing supply chain operations.
• Collaborate with cross-functional teams and external partners to manage logistics for drug substances and finished goods.
• Develop and refine SOPs, work instructions, and quality documentation to enhance logistics processes.
• Support audits and inspections by providing comprehensive documentation and process insights.
• Monitor and maintain GxP compliance across third-party logistics providers and external collaborators.
• Implement process improvements to elevate 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 required.

Key Responsibilities & Duties

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

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.
• Proficiency in Veeva QMS, with expertise in managing change control workflows.
• Strong understanding of GxP, GDP, and GMP regulations and their application.
• Experience collaborating with external manufacturing and logistics partners in a global context.
• Excellent leadership, communication, and project management skills.
• Experience in rare disease or small-batch pharmaceutical manufacturing is preferred.
• Familiarity with regulatory filing impacts and country-specific logistics requirements.
• Ability to manage multiple concurrent change control records and drive cross-functional alignment.