Product Features
Blog
Contact Us
Sign In
Shionogi Europe
,
London, Greater London
Associate Manager, Clinical Quality
Overview
Job Description
Description Being innovative, thinking differently, collectively working together are all fundamentals of our culture. We have strong record taking research through to new product, with three products gaining market authorisation in the last twelve months. As we continue in our clinical development, we have a strong compliance culture that makes us successful. As an Associate Manager Clinical Quality you will be a key member of the Quality team, serving as the GCP subject matter expert. You will be responsible for supporting the design, set up, maintenance and delivery of our robust GCP compliance projects and quality systems and processes. This includes the planning and conduct of audit programmes. As it a small team you also support GVP Quality. Your other duties will include: * Ensuring compliance with regulatory standards, protocols, and company policies and SOPs * Continuously build and innovate in all aspects of GCP Compliance * Managing and performing/handling GCP investigations regarding Quality Issues, Misconduct Investigations including Serious Breaches etc. * Manage and identify potential systemic compliance risks including Investigations of deviations and monitoring of corrective actions and preventative (CAPA) relating to non-compliance issues and findings * Assist in the development and implementation of training strategies and programmes * Development and enhancement of the Quality Management System * Write and revise QA Standard Operating Procedures (SOPs). As Associate Manager we are looking for you to have a background in GCP quality, or have experience of clinical operation and have made your first step into quality. * Experience in a compliance role in pharmaceutical industry, with responsibility for GCP and applicable legislation * Experience in having worked in a matrix global environment, especially in an outsourced model with CROs/vendors across multiple geographies * Extensive knowledge and practical hands-on experience in GCP, ICH and applicable legislation * Comprehensive understanding of pharmaceutical regulatory requirements and impact on the various functions within the business * Ability to develop and manage efficient and effective compliance systems * Excellent planning and organisational skills To be successful, you will be a self-starter, who is inquisitive and professional. If you are interested in the position, please do apply.