Regional Quality Assurance Director

Company: MARKEN LLP
Location: Durham
Posted on: September 13, 2020

Job Description:

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Regional Quality Assurance Director Full Time Durham, NC, US

5 days ago Requisition ID: 1222

Main Purpose:

The Regional Quality Assurance Director is responsible for the implementation of the Quality process and procedures and regional policies required to manage and control Marken’s Storage and Distribution facilities in the region of responsibility to ensure compliance with Good Manufacturing Practice (GMP), ISO 9001, Good Distribution Practice (GDP) and regional and local regulations and requirements. In addition, this person may act as Sanitary Responsible (SR) or Technical Director (TD) for a specific Marken CTD facility.

As SR/TD, is responsible for the administration, organization and Operation of the Depot. The review and update of all legal documentation according to the business activities, evaluation of personnel qualifications, and oversight of job descriptions. In addition, the SR/TD ensures that the facilities, utilities and equipment is maintained and does not affect the identity, purity, safety, quality of the medicines. He/she is responsible to attend and support inspection visits, performed by the local Authority.

Main Duties and Responsibilities:

Develop, implement, communicate and maintain a quality plan to sustain the Company’s quality systems and policies at the facilities in the region of responsibility, in compliance with quality system requirements.

As a leader for Quality for the entire Marken region, develop and mentor Quality personnel. Create and execute succession planning, resolve and facilitate HR related issues.

Provide Quality Assurance leadership and oversight of the Logistics Quality Coordinators to ensure consistent implementation of and compliance to the Marken Quality Management System at all Logistics locations.

In conjunction with the Global CTD Quality Director, set quality assurance objectives and ensure targets are achieved through effective quality performance monitoring, measurement, analysis and reporting.

In conjunction with the CTD Quality Assurance Group, the Regional Quality Assurance Director will assist with the implementation of policies and standards across the business and in the management of the CTD Quality Management System (QMS) in accordance with GMP and GDP as appropriate.

Interact with client Quality organizations to resolve quality issues, prepare and review QTAs, create and control customer specific documents.

Depending on the country regulation where is based, may act as Sanitary Responsible / Technical Director, to ensure regulatory compliance of the facility and its operations.

In the role of SR/TD, liaise with Ministry of Health (MoH) in relation to regulatory submissions and authorizations.

Effectively interact with other depot Quality managers, operations managers and stakeholders to maintain quality and help introduce new quality objectives.

Develop and implement Continuous Quality Improvement process and tools

Keywords: MARKEN LLP, Durham , Regional Quality Assurance Director, Other , Durham, North Carolina