My client, a well-known 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 a focus on Computer System Validation (CSV) audits. Additional tasks include supporting the continuous improvement of the Quality System, inspection management, regulatory intelligence activities, SOP and WP management, and project liaison activities. You will work 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 the company's Quality System. Support inspections. Support the audit process. Support Regulatory Intelligence. Support the management of global, regional, and local Standard Operating Procedures (SOPs) and Working Practices (WPs). Support the validated state of computerized systems. Provide advice and act as project liaison. Skills & Experience
Degree in natural science or equivalent business experience. Several years of experience in the Information Technology (IT) industry, pharmaceutical industry, medical devices industry, Regulatory Authority, or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance, Clinical Development, Computerized System Validation, and Data Integrity. Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Computerized 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 computerized systems in the GxP environment, with experience in software validation and/or development. Understanding of computer hardware and network/infrastructure requirements.
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The main task is to manage and perform audits with a focus on Computer System Validation (CSV) audits. Additional tasks include supporting the continuous improvement of the Quality System, inspection management, regulatory intelligence activities, SOP and WP management, and project liaison activities. You will work 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 the company's Quality System. Support inspections. Support the audit process. Support Regulatory Intelligence. Support the management of global, regional, and local Standard Operating Procedures (SOPs) and Working Practices (WPs). Support the validated state of computerized systems. Provide advice and act as project liaison. Skills & Experience
Degree in natural science or equivalent business experience. Several years of experience in the Information Technology (IT) industry, pharmaceutical industry, medical devices industry, Regulatory Authority, or otherwise relevant experience, preferably including Quality Assurance for Manufacturing, Pharmacovigilance, Clinical Development, Computerized System Validation, and Data Integrity. Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Computerized 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 computerized systems in the GxP environment, with experience in software validation and/or development. Understanding of computer hardware and network/infrastructure requirements.
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