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Regional Quality Assurance Director Full Time Durham, NC, US
5 days ago Requisition ID: 1222
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
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
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
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
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
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