Senior Manager, Quality Management Systems

DP World•Chicago, IL

About The Position

We are the leading provider of worldwide smart end-to-end supply chain & logistics, enabling the flow of trade across the globe. Our comprehensive range of products and services covers every link of the integrated supply chain – from maritime and inland terminals to marine services and industrial parks as well as technology-driven customer solutions. As a Senior Manager over Quality Management Systems - Healthcare , you will oversee the implementation and maintenance of Good Distribution Practice (GDP) and relevant ISO standards across our healthcare logistics sites within the region. Your role ensures that compliance requirements are consistently met, while supporting local GDP representatives and quality assurance teams in safeguarding the integrity of pharmaceutical products throughout the supply chain. You will act as a key point of contact between local site teams, regional logistics, external partners, and regulatory authorities, coordinating efforts to maintain certification and address compliance issues. While not at the strategic leadership level, this position carries responsibility for ensuring operational excellence and regulatory conformity across multiple sites.

Requirements

Bachelor's degree
Minimum of 5 years of proven operational / industry / relevant experience at senior manager level in the healthcare and pharmaceutical supply chain
Proven experience in the leadership of regional teams, subject matter experts, ideally in matrix structures
In-depth knowledge of GDP guidelines, GxP standards, and local regulatory requirements
Strong background in quality management (ISO 9001, 13485, 14001, 45001 and TAPA) systems, audits, validation
Project management and implementation expertise a plus
Experience in Logistics, Quality Management System standards/GDP, and healthcare customer supply chain
Please note : This position does not offer sponsorship for employment visas. Applicants must be legally authorized to work in the United States without sponsorship now or in the future.

Responsibilities

Lead gap analyses to ensure GDP requirements and relevant ISO standards are integrated into local quality management systems (QMS) and monitor regulatory changes impacting the region
Coordinate compliance assessments for new business opportunities/acquisitions by reviewing GDP standards and managing the integration of new sites into regional quality structures
Work with the Global Healthcare Team to drive improvements in the regional GDP and Quality compliance system by defining operational standards, tracking KPIs, and supporting benchmarking activities
Align with the global team to develop, oversee, and deliver training programs for GDP-relevant functions, ensuring staff receive appropriate awareness and qualification opportunities
Manage implementation plans for regional GDP-certified locations, working with business unit heads to establish certification processes and maintain compliance networks
Participate in outsourcing activities by ensuring quality agreements are in place and leading audits of service and transport providers
Provide guidance to local Quality Managers in our Healthcare operations, coordinating activities across countries and ensuring alignment with regional and global objectives
Support operations during regulatory inspections and external audits by preparing documentation and guiding teams through compliance requirements
Ensure route risk assessments are completed and that the Validaide system is effectively applied across regional operations
Advise commercial teams with subject matter expertise during tenders and business reviews, ensuring compliance considerations are addressed
Monitor compliance KPIs across regional teams, ensuring timely reporting and alignment with global objectives
Oversee CAPA management by tracking progress, ensuring timely closure, and escalating unresolved issues when necessary
Provide regular updates and compliance reports to regional leadership, highlighting risks, progress, and improvement opportunities