Quality Manager – Life Sciences – F/M

Company Description

Our client, one of the world´s leading pharmaceutical company, is currently looking for their Quality Manager.

Job Description

Your responsibilities:

• Reporting to the Senior Director Quality & Compliance, your main duties are to:
• Manage QMS and relevant regulatory activities in accordance with applicable standards and regulation and guarantees the application of ISO13485, MDSAP & 21CFR part 820.
• Manage key Quality processes at the assigned site (NCMR, CAPA, Change Control, Documentation control, Production Batch record review…) as required by the applicable QMS.
• Manages local QC team at the assigned site
• Identify potential or real non-conformities related to the products, processes and quality management system,
• Organize and ensure proper QA related training to assigned manufacturing site employees,
• Provide necessary documentation to constantly ensure on time release of batches from assigned site,
• Participate to the establishment and execution of internal audits program,
• Participate to risk management activities, to corporate meetings (QA meeting, work session, …) and to continuous improvement by identifying innovative solution, tools, software to support day to day activities,
• Act as back up for the Regulatory Affairs and Quality Assurance team when requested,
• Supervise and Manage the Quality Assurance and Quality Control team at the assigned site
• Review and approve SOPs and Policies only p.o (per order) for the Senior Director Quality and Compliance

Profile

• Master / Engineer’s degree in a biomedical / scientific,
• At least 5 years’ experience in Quality ideally in the pharmaceutical/medical devices industry (development, manufacturing)
• Strong knowledge of management of quality system (21 CFR part 820, ISO13485, MDSAP)
• Knowledge of GMP environment
• At ease with Microsoft Office and usual software tools
• Fluent in German and English.

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