My client a well know pharma company is seeking an experienced Senior Manager, Global Quality Management to join their Global Quality Management team.
Based in Berkshire my client offers a generous package including a competitive salary, car allowance and bonus.
You must have worked within the pharmaceutical industry with experience in GxP related CSV audits and inspections Role The main task is to manage and perform audits with focus on Computer System Validation (CSV) audits.
Additional tasks are to support the continuous improvement of the Quality System, the inspection management, the regulatory intelligence activities, the SOP and WP management, and the project liaison activities Working in close collaboration with the Head of Global Quality Management of GCP, CSV & GVP, Senior Director Global Quality Management and the CSV Audit Lead: Key Accountabilities Support the development, implementation, continuous improvement and documentation of Companies' Quality System Support inspections Support the audit process Support Regulatory Intelligence Support the management of the global, regional and local Standard Operating Procedures (SOPs) and Working Practices (WPs) Support the validated state of computerised systems Provide advice and act as project liaison Skills & Experience Degree in natural science or equivalent business experience Several years of Information Technology (IT) industry/pharmaceutical industry/medical devices industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance and Clinical Development and Computerised System Validation and Data Integrity Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Computerised System Validation, Data Integrity, Manufacturing, Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance Experience as a Lead Auditor on internal audits and external vendor audits.
Experienced in GxP related CSV audits and inspections Knowledge and understanding of computerised systems in the GxP environment, experience in software validation and/or development Understanding of computer hardware and network/infrastructure requirements