Director of Global Quality Management - Life Sciences

The Director of Global Quality Management - Life Sciences is responsible for leading and managing the global quality management strategy within the company's specialized freight forwarding operations. This includes ensuring compliance with International Organization for Standardization (ISO) 9001/14001, The International Air Transport Association (IATA) /Center of Excellence for Independent Validators (CEIV), Transported Asset Protection Association (TAPA), World Health Organization - Europe (WHO/EU) Good distribution practice (GDP), storage specific good manufacturing practice (cGMP) relevant local authorization e.g. Wholesale Distributor Authorization (WDA)/ Manufacturing and Importer Authorization (MIA) and/or other local regulatory requirements. The role involves driving quality standards across a complex, multi-location network, while managing a global team of Quality Managers and Assurance professionals to ensure the highest standards of compliance and operational excellence. The Director of Global Quality Management will oversee quality processes, regulatory compliance, audits, and continuous improvement initiatives, while also leading a global team, each with specific needs depending on local regulatory and operational requirements in Life Sciences & Healthcare logistics.

• Responsible for ensuring services and processes are in compliance with the AIT's Quality Assurance (QA) standards, international standards, and government regulations. Lead global quality assurance efforts across multiple locations, ensuring full compliance with ISO 9001/14001, IATA CEIV, TAPA, WHO/EU GDP, cGMP/API/WDA/MIA and other relevant global and local regulations
• Lead the development, implementation, and maintenance of the electronic Quality Management System (eQMS), ensuring it is adapted to specific local requirements while maintaining global standards. Negotiate service level agreements of supplier quality management activities include, performance/quality metrics, and ensuring contractual obligations are met; resolving vendor/supplier problems related to quality, performance, quantity.
• Ensure each LS location adheres to regulatory standards specific to their region, working closely with local Quality Teammates to tailor strategies to their specific needs. Monitor and manage the performance of the eQMS, ensuring all assigned locations maintain certifications and pass internal and external audits
• Ensure that local quality teams are equipped with the tools, training, and guidance needed to manage compliance with local regulations and other regional standards. Lead, mentor, and manage a global team of Quality Managers and Assurance Teammates, fostering a culture of accountability, compliance, and continuous improvement.
• Develop and implement tailored quality management programs for specific regions, taking into account varying regulatory environments, customer expectations, and operational challenges. Directly oversee Quality Managers at multiple global locations, ensuring that they are equipped to meet both global and local compliance requirements.
• Provide leadership to the quality teams in responding to local and global audits, developing CAPA processes, and ensuring ongoing regulatory compliance. Build and maintain strong communication channels between global and regional quality teams to ensure consistency in quality standards and operational practices.
• Use key quality metrics (KPIs) to identify areas of improvement and lead initiatives to increase operational efficiency, reduce non-conformance rates (NCRs), and enhance customer satisfaction together with the Key Stakeholders in the various regions and organization. Address and investigate customer complaints regarding quality, implementing corrective actions as needed.
• Ensure effective implementation of Corrective and Preventive Actions (CAPA) to address systemic issues and maintain high-quality standards globally together with the Key Stakeholders in the various regions and organization. Keep up-to-date with the latest industry practices, client and regulatory expectations and new regulations, feeding down into the Quality team and across the business processes.
• Act as the key liaison between the global quality team, clients, suppliers, and internal stakeholders, ensuring alignment on quality expectations and compliance requirements. Work closely with local teams to maintain effective relationships with suppliers, ensuring they meet global quality standards while addressing region-specific needs. Attend industry events to ensure latest best practices and thinking is known and being implemented into the global QMS.
• Lead global QA projects and initiatives, ensuring successful delivery of GxP compliance projects for customers, suppliers, and LS locations across various regions. Provide Monthly Management updates, Oversee global change control efforts, ensuring that any updates to global regulations or operational practices are implemented seamlessly across all LS locations.
• Performs other duties as assigned
• Complies with all policies and standards

Education
• Bachelor's Degree Education: Bachelor’s degree in Life Sciences, Engineering, Logistics, or a related field. An advanced degree (e.g., MBA, MSc) is preferred. (Required)

Experience
• 15+ years Work experience in Freight Forwarding industry with process familiarity in air, ocean and domestic services required. Experience in Quality Management Systems. (Required)
• 10+ years work experience in global quality management with a focus on Life Sciences, Healthcare, or pharmaceutical logistics. (Required)
• 10+ years Proven experience managing global teams, particularly in ensuring compliance with ISO, GDP, cGMP and regional regulations. (Required)

Knowledge, Skills, and Abilities
• Proficient in Microsoft Suites, Tableau and Power BI High
• Formal quality experience required (ISO 9001, Lean, and/or Six Sigma) High
• Strong background in quality investigations, quality inspection methods, and statistical analysis High
• Demonstrated leadership abilities and strong business acumen. High
• A proven record of successful cross-functional teamwork High
• Excellent communication skills both written and oral skills, and the ability to make concise & compelling presentations. High

Licenses and Certifications
• Lean Six Sigma Certification-IASSC - GDP and sector related programs, PMO Upon Hire (Required) and
• GDP and section related programs Upon Hire (Required)

AIT Worldwide Logistics is a global freight forwarder that helps companies grow by expanding access to markets all over the world where they can sell and/or procure their raw materials, components and finished goods. For more than 40 years, the Chicago-based supply chain solutions leader has relied on a consultative approach to build a global network and trusted partnerships in nearly every industry, including aerospace, automotive, consumer retail, energy, food, government, high-tech, industrial, life sciences and marine. Backed by scalable, user-friendly technology, AIT’s flexible business model customizes door-to-door deliveries via sea, air, ground and rail—on time and on budget. With expert teammates staffing more than 150 worldwide locations in Asia, Europe and North America, AIT’s full-service options also include customs clearance, warehouse management and white glove services.