Senior Manager, Quality Management Systems

Proclinical is seeking an expert in Quality Management Systems for a Senior Manager position. The successful candidate will be required to focus on ensuring the effectiveness of Quality Management System processes and driving continuous improvement. An urgent requirement is to establish key performance indicators to monitor the health of Quality Systems.

Responsibilities:

• Lead EMEA Quality Audit Management and implement a consolidated supplier risk assessment and audit plan.
• Deploy and manage new Risk Management processes across EMEA QA Functions, driving risk mitigation activities.
• Establish a Learning Management System Training Matrix for GxP/ISO compliance.
• Ensure continuous compliance with EU pharmaceutical, distribution, and medical device regulations.
• Develop, standardize, and improve the EMEA Quality Management System with robust policies and procedures.
• Manage the EMEA Quality Audit Plan to ensure inspection readiness and maintain a qualified auditor pool.
• Support quality operational tasks and cross-functional projects related to the EMEA QMS.
• Serve as a backup for the SAP Quality Module Key User for EMEA.

Key Skills and Requirements:

• Degree in chemistry, pharmaceutical, biotechnology, or life sciences.
• Experience in the pharmaceutical or medical device industry.
• Proficiency in GxP and Quality Management Systems.
• Skills in Project Management, Quality Risk Management, and Root Cause Analysis.
• Familiarity with e-QMS tools like Veeva and Trackwise, and SAP systems.
• Competence in Power BI and GxP Auditing.
• Experience in Risk Assessment within a GxP environment.
• Fluent in written and spoken English.

If you are having difficulty in applying or if you have any questions, please contact George Kyriacou at g.kyriacou@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.