Regional Healthcare Quality Manager

Expeditors•Bellevue, WA

4d•$85,000 - $95,000•Remote

About The Position

This role involves interpreting and translating government and industry regulatory guidelines for Expeditors' operations and processes, particularly within the healthcare sector. The manager will establish Expeditors' standards based on good distribution practices, assist in developing internal audit and self-assessment processes, and support districts with external audits. A key part of the role is collaborating with the Service Provider Management group to create compliance guidelines for various partners and developing and delivering training on healthcare compliance topics. The position also requires developing a risk assessment process, ensuring the Expeditors CAPA process is followed, and communicating regulatory changes. The manager will support network compliance through various documentation and participate in management review meetings, establishing a communication plan to enhance the visibility of regional healthcare activities. Tactically, the role involves recognizing and interpreting regulatory guidelines per government jurisdiction, communicating with the Trade Compliance group regarding government interactions, and collaborating with internal Expeditors entities to establish compliant operations. The manager will develop guidelines for different geographies, products, and services, and maintain Expeditors' standards to align with evolving regulations. They will also work with internal auditors to develop audit processes and assist geographies, products, and services in preparing for audits. A critical responsibility includes performing investigations into significant supply chain incidents related to import and export, ensuring root cause identification and the implementation of corrective and preventative actions, as well as reviewing and participating in deviation and change control processes.

Requirements

Must have full working knowledge of regulatory requirements for assigned territories.
Strong quality and compliance background
Understands impact of decisions and actions on business and consults with appropriate colleagues and management as applicable.
Is recognized as a knowledgeable resource within the department on healthcare topics.
Understands current global and regional trends in regulatory compliance.

Nice To Haves

QA GDP/GMP pharma and medical device experience preferable.

Responsibilities

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.
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.