Regional Healthcare Quality Manager

Expeditors•Bellevue, WA

3d•Remote

About The Position

This role involves interpreting and translating government and industry regulatory guidelines for healthcare compliance within Expeditors' operations. The manager will establish Expeditors' standards based on good distribution practices, assist in developing internal audit processes, and support districts with external audits. Collaboration with Service Provider Management is key to developing compliance guidelines for various partners. The position requires developing and presenting training materials on healthcare compliance, including general awareness, compliant shipment processes, product handling, GDP SOPs, and supplier handling. A critical aspect is developing a risk assessment process and ensuring the Expeditors CAPA process is followed, along with communicating regulatory changes and supporting network compliance through documentation like FAQs and checklists. Ensuring thorough documentation for compliance and audits, and participating in executive/regional management review meetings are also key duties. A communication plan to enhance the visibility of regional healthcare activities is to be established.

Requirements

Full working knowledge of regulatory requirements for assigned territories.
Strong quality and compliance background.
QA GDP/GMP pharma and medical device experience preferable.
Understands impact of decisions and actions on business and consults with appropriate colleagues and management as applicable.
Recognized as a knowledgeable resource within the department on healthcare topics.
Understands current global and regional trends in regulatory compliance.

Responsibilities

Interpret and translate government and industry regulatory guidelines and requirements applicable to Expeditors' operations and processes.
Establish Expeditors standards based on 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.
Develop and present training material for all aspects of healthcare compliance, including general awareness, compliant shipment process for all products, compliant product handling in healthcare facilities, training on GDP SOPs, and compliant supplier handling.
Develop risk assessment process and ensure Expeditors CAPA process is followed.
Communicate changes in regulations and Expeditors standards.
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.
Recognize and interpret regulatory guidelines per government jurisdiction.
Communicate with the Trade Compliance group regarding government visits and audits.
Collaborate with other entities within Expeditors (Product, Service, GEO) to establish compliant operations and processes.
Develop guidelines applicable to different geographies, products, and services.
Maintain and update Expeditors standards to remain current with changing regulatory guidelines.
Work with internal auditors to develop audit processes.
Assist geography, product, and services in preparing for audit processes.
Perform investigations into significant supply chain incidents related to import and export, ensuring root cause identification and implementation of corrective and preventative actions.
Review and participate in deviation and change control to ensure appropriate investigation, assessment, and implementation/monitoring of actions.