Global QA and Regulatory Assurance Mgr

Job Description

We are seeking a Global QA and Regulatory Assurance Manager to drive compliance to quality and regulatory topics across DHL Supply Chain globally. This person will oversee the deployment of customer, regulatory, and industry requirements within the organization, including compliance oversight, and serve as a subject matter expert (SME) for quality and regulatory assurance topics across assigned areas (e.g., GDP, ISO 9001, ISO 13485; 4PL, Transport business).

• Creates, maintains, and implements quality standards across DHL Supply Chain globally.
• Prepares for and represents customer projects throughout all stages, especially in the 4PL business (Lead Logistics Partner, Service Logistics) and Transport.
• Elaborates and reviews customer documentation such as Quality Agreements, SOPs, WIs, and customer presentations for new business opportunities, renewals, and project updates.
• Assists global quality senior leaders in delivering to the Quality and Regulatory agenda.
• Leads updates and continuous improvement for the global Quality Management System activities to meet industry standards, customer needs, and regulatory requirements, including creating SOPs, WIs, and training.
• Ensures industry standards and regulatory requirements are included in SOPs, WIs, and training materials.
• Manages audit activities by creating and maintaining audit programs, conducting internal and supplier audits, and organizing customer/regulatory audits as applicable.
• Creates, follows-up, and performs critical review of CAPA/Change requests.
• Supports the preparation of Quality Performance reports and Management Review meetings, including CAPA, deviation, and risk management.
• Develops and provides training on quality and regulatory compliance.
• Works closely with cross-functional teams, including Business Development, Sales, Operations, Operations Excellence, and other functions-related, to ensure quality and regulatory requirements are integrated into projects and initiatives.

Required Education and Experience

• Bachelor’s Degree in Life Sciences, Pharmacy, Biomedical Engineering, Quality Management, or related field, required.
• Master’s Degree in the above fields, preferred.
• Qualified Lead Auditor experience (e.g. ISO 9001, ISO 13485, GDP), required.
• Training and qualifications in problem solving, FMEA, and risk management, required.
• In-depth understanding of quality management systems (QMS) and regulatory requirements, required.
• Minimum five (5) years’ experience in Quality, Regulatory Assurance functions, required.
• Previous experience in the Life Sciences or Pharma industry, required.

Our Organization

We offer a business casual environment, focus on teamwork, associate development, training, and continuous improvement. Our benefits include competitive wages, excellent affordable insurance benefits (including health, dental, vision, and life), 401K plan, paid vacation and holidays. We are an equal opportunity employer.