implement comprehensive quality management strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g. FDA, EMA, etc.) and industry standards (e.g. GMP, GDP, GCP). Provide leadership and direction to the quality assurance and quality control teams, fostering a culture of quality excellence, accountability, and continuous improvement. Establish and more »
Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits more »
Cambridge University Hospital NHS Foundation Trust
at Cambridge University Hospitals. The Data and AI Research Governance Coordinator is responsible for providing expert advice for a portfolio of research involving NHS clinical informatics and AI across a wide range of specialties, throughout the life course of the research project. The post holder will assist with the … initiative. We are an inclusive department and offer flexible working arrangements. Main duties of the job This post does not involve directly working with clinical data. The role holder will provide advice and support to researchers in all aspects of data and AI research governance, including submitting applications to … Knowledge and understanding of research funding streams and award bodies Qualifications Essential Educated to degree level or equivalent experience Desirable Post graduate research qualification GCP Trained Skills Essential Excellent communication skills Excellent organisational and planning skills Excellent interpersonal skills including the ability to build working relationships with department colleagues, Trust more »
