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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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