New job DIRECTOR OF QUALITY

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Group: Job Openings, Job Leads and Job Connections! Subject: DIRECTOR OF QUALITY Andy Cuthbert posted a job: DIRECTOR OF QUALITY "IN VITRO DIAGNOSTICS Based North West England Attractive, Negotiable Salary + Full Benefits Already established as a world leader in sample and assay technologies, our client continues to drive its presence forward in companion diagnostics and personalized medicine Their mission is to ensure their customers achieve ultimate success and breakthroughs in life sciences, applied testing, pharma and molecular diagnostics, thereby driving improvements in quality of life. They now wish to appoint an experienced Director of Quality who will play a fundamental role in driving quality strategies forward, underpinning their outstanding image in the market place. In this strategic role, reporting into the VP of Quality, you will direct regulatory submissions required for global approvals of IVDs, liaising with the regulatory team when necessary, whilst leading complex quality development tasks and issue resolution. This will require in-depth evaluation, involving multiple quality, regulatory, or technical factors. There is a requirement for both internal interactions with senior management and externally with regulatory bodies, including direct contact with the FDA. With four direct reports, comprising a validation lead, compliance lead, QA and QC leads, you’ll have overall responsibility for a team of 22, which is growing, and you’ll have the ultimate task of advancing the company’s quality system through the management of key projects, programmes and communication forums. You’ll have strong and demonstrable experience of leading all aspects of quality with respect to IVD manufacture, possess face-to-face exposure in dealing with the FDA and a clear, decisive management style, combined with the ability to work cross-functionally with other teams within the organisation. You’ll possess the ability to negotiate complex matters across a broad spectrum of sites and corporate issues and have responsibility for the overall health of the company’s Quality System. The innate ability to mentor direct staff and their subordinates is required, ensuring their development in line with organisational and company objectives. In return, you’ll receive an excellent remuneration and benefits package, combined with the opportunity to join a globally respected and constantly growing market leader. To learn more contact Andy Cuthbert, and send your CV to andy@phfrecruitment.co.uk"

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