Quality Manager

Job description

About this role TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. The Quality Manager is a position in the Quality Systems or Quality Operations Teams, Quality & Compliance Department. The Quality Manager facilitates the generation and revision of all Quality Management System (QMS) Documents; supports the risk assessment, Root Cause Analysis and Corrective Action Preventive Action (CAPA) Plan generation for all Quality Events; drives the completion of relevant quality sections of Request for Proposal (RFP)/ Request for Information(RFIs)/quality assessments; assists with the Computer System Validation (CSV) of all systems across the company; prepare, conduct and follow up internal and vendor audits and the management of the resultant CAPA; assists with hosting external audits This person has experience in clinical research and quality assurance and is able to provide support and advice throughout this area. RFIs: Provides input into t...