Global QA and Regulatory Assurance Mgr in Westerville, Ohio at Supply Chain

Global QA and Regulatory Assurance Manager

Would you like to join the Logistics Company for the World? DHL Supply Chain is just that.

Become an essential part of everyday life, by contributing to an organization that is Connecting People and Improving Lives. If you have a passion for people, a desire to problem-solve, and eagerness to pursue continuous improvement opportunities… we look forward to exploring career possibilities with you!

Job Description

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

Responsibilities

• 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.
• Elaboration and review of customer documentation such as Quality Agreements, SOPs, WIs and customer presentations for new business opportunities, renewals, 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.
• Prepares materials, updates and follow-up of quality leadership team meetings, especially for LLP, SL and Transport.
• 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 has a business casual environment and focuses on teamwork, associate development, training, and continuous improvement. We offer competitive wages, excellent affordable insurance benefits (including health, dental, vision and life), 401K plan, paid vacation and holidays.

Our Organization is an equal opportunity employer.