Director Quality Operations EMEA
il y a 3 semaines
Description
:
Experience leading multiple sites and teams.
Direct experience with compliance to the GLP regulations and ISO 17025 in a research laboratory.
Oversite of the GLP master schedule and inspections.
Leading and overseeing implementation of the eQMS application in EMEA.
•Responsible for leading the Quality Assurance, Document Control, Archives, Engineering and Metrology processes in support of Laboratory Services activities and ensure compliance with ISO 17025, ISO 27001, OECD GLP, 21 CFR 11, 21 CFR 58, and EU GDPR and others as applicable;
Plan, manage and coordinate the activities of the Quality Assurance program within the NAMSA EMEA laboratories.
BAC+5 in a scientific discipline required.
15 years of experience in the field required, including 5 years management experience.
Experience with regulatory interfaces.
Fluency in English and French, required. German language skill is a plus.
Thorough knowledge of global GxP/ISO standards/regulations. Ability to interpret new regulations and apply knowledge quickly. Maintains professional skills in Quality Assurance and the biomedical industry in general.
Ability to provide work direction, to include organizing, prioritizing, negotiating, communicating relevant project information and scheduling work assignments.
Ability to handle multiple priorities and issues, foster a cooperative work environment with high quality standards, and facilitate and manage effective meetings.
Must be familiar with a broad range of scientific applications sufficient to allow for the understanding and sound risk assessment of NAMSA products and processes.
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