QA/RA Director

Lead the Quality Regulatory department Client Details Fastest growing Diagnostic organisation Description The Director is responsible for assuring that every aspect of the quality system is suitably built and deployed and that the organisation understands, embraces and employs sound quality methodologies in all its work affecting product Responsible for building, developing and maintaining a team of competent, committed and qualified Quality and Regulatory professionals who lead the Quality and Regulatory function to serve the business needs. Create and manage key performance indicators for product quality, quality system performance and regulatory compliance and ensure dissemination and understanding of these across the organisation. Establish and maintain the Quality System in compliance with global process and to applicable international QS standards including ISO13485 and FDA CFR Part 820. Continually develop QMS to ensure it effectively and efficiently meets evolving business needs. Manage operations quality activity across the site from incoming quality through manufacturing, packaging and final product release by ensuring the required competent resources and operational capacity is in place to meet business needs. Manage supplier quality processes by establishing effective, efficient and compliant systems for both external and internal supplier base. Engage collaboratively with global QA/RA functions and other sites to align on delivery of effective and efficient quality and regulatory service for the business Site Management Representative - lead, achieve and maintenance of site registrations. Lead site preparation and management of external audits Manage complaints and post market surveillance process in collaboration with global quality and regulatory partners. Ensure effective QA/RA role as key member of a cross functional team in the introduction of new products and process validation. Lead execution of QA/RA deliverables. Lead creation directly and in collaboration with Global Regulatory of product regulatory filings to ensure timely currency of product registrations. Lead in creation of initiatives which represent the sites program of continuous improvement in quality and assist in development of appropriate action plans for the accomplishment of this agenda. Profile Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820. Experience of managing and hosting regulatory agency and customer audits. Proven and demonstrable experience of working in an IVD or medical device environment or similar with relevant experience in a significant QA/RA people management and leadership role. Previous experience of managing product release of medical device/IVD products. Previous experience of aligning global company quality requirements and implementing resulting systems in local sites Previous experience of managing multiple sites Experience of managing and developing a high performing team Experience of manufacturing and post launch IVD or medical device activities Scientific/Technical background with Master's degree in technical field. Ability to use problem solving tools and methodologies. Influence internal team and external parties to maximise success opportunities. Knowledge and experience in High volume manufacturing Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping) Job Offer Financial package above market average The opportunity to lead the Quality department and be a key player in the company growth

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