Regional Healthcare Quality Manager

Company Description

Expeditors is a Fortune 500 global logistics company headquartered in Bellevue, Washington. With more than 19,000 employees in 350+ locations across six continents, we provide customized supply chain solutions, transportation, customs brokerage, warehousing, distribution, and logistics technology services. We are committed to developing our people, promoting from within, and delivering exceptional service to customers worldwide.

Job Description

Responsibilities and Duties This section lists job-specific tasks and duties, such as the ones listed below, that are completed on a regular basis by the District Training & Personnel Development Manager. This list may be edited to the specific job role.

Sustain and Protect:

• Interpret and translate government and industry regulatory guidelines and requirements that apply, as appropriate, to Expeditors operations and processes.

• Establish Expeditors standards based on the commonly understood and application of applied good distribution practices guidelines.

• Assist in establishing an internal audit process Self-Assessment process.

• Support Districts for external audits as appropriate.

• Collaborate with Service Provider Management group in developing service provider compliance guidelines for air and ocean carriers, facility operators, and packing suppliers, etc.…

• Develop and present, as appropriate, training material for all aspects for healthcare compliance to include but not limited to:• Healthcare requirements General Awareness

• Compliant shipment process for all products

• Compliant product handling in healthcare facilities

• Training on GDP SOPs

• Compliant supplier handling

• Develop risk assessment process and ensure Expeditors CAPA process is followed.

• Communicate changes in regulations and Expeditors standards, as appropriate

• Support network compliance through preparation of FAQ docs, supportive checklists, posters, etc.…

• Ensure that all processes and activities are thoroughly documented and retrievable to support compliance requirements and audits.

• Participate in an annual Executive/ Regional Management Review Meeting.

• Establish a communication plan to increase visibility of healthcare activities of the region.

Tactical Execution:

• Recognize and interpret the regulatory guidelines per government jurisdiction, as appropriate.
• Communicate with the Trade Compliance group as it relates to government visits and audits to ensure Expeditors meets these compliance requirements.
• Collaborate with other entities within Expeditors – i.e. Product, Service and GEO to establish compliant operations and processes.
• Develop the guidelines, as appropriate, to apply to different geography’s, products and services.
• Maintain and update Expeditors standards to remain current with changing regulatory guidelines.
• Work with internal auditors to develop audit process
• Assist geography, product and services, as appropriate, to prepare for audit process
• Perform investigations into significant supply chain incidents related to import and export and ensure root cause is identified, and appropriate corrective and preventative actions are implemented.

Review and participate in deviation and change control to ensure appropriate investigation and assessment is carried out and actions implemented and monitored.

Physical Demands This section lists physical demands required of this job and may be edited to the specific job role.

• Use of standard office equipment - computer with keyboard and mouse, phone, fax/copy/scan machine, etc.
• Write with pencil/pen/marker
• Functions performed primarily while seated at desk

Stand for varying periods of time while delivering training classes.

Qualifications

This section lists desired qualifications for the job and may be edited to the specific job role.

• Understands impact of decisions and actions on business and consults with appropriate colleagues and management as applicable.
• Must have full working knowledge of regulatory requirements for assigned territories.
• Is recognized as a knowledgeable resource within the department on healthcare topics
• Understands current global and regional trends in regulatory compliance
• Strong quality and compliance background
• QA GDP/GMP pharma and medical device experience preferable.
• Responsibility will be delegated to other Regional Quality Managers in the event of absence. This will be communicated through the “out of office” messaging system.

Additional Information

May be located in any district in North America Salary range: $85,000-$95,000 All your information will be kept confidential according to EEO guidelines.