One of the largest biotechnology companies in Germany is looking for a QC Manager to head their QC team at their main site near Berlin. This is a leadership position, reporting into the Director of QA & Compliance, and is the most senior QC employee on site.
In this position you are managing the Quality Control department of the company and setting the direction for achieving added value by implementing and following various QC processes according to international standards and regulations (e.g. ISO 13485, MDSAP, GMP)
Key responsibilities of the QC Manager include:
- You lead and manage the Quality Control team regarding effectiveness and efficiency.
- You evaluate and verify employee performance through the review of completed work assignments and achieved objectives.
- You secure compliance of Quality Control practice to SOPs, establish structures to keep all documents lean and updated and to perform internal quality checks of procedures, reagents and instruments according to the Quality Management System.
- You ensure that quality control processes are established, implemented and maintained within the organization as required by standards and regulations e.g. ISO 13485, 21 CFR 820, IVDR 2017/746.
- Participate in internal and external audits according to schedule.
- You act as primary liaison for QC topics between this and other company sites, well as other Corporate stakeholders worldwide.
- You identify training needs, develop training concepts and manage training for QC related processes of personnel on site.
- You participate in projects related to product, processes or infrastructure topics on a as needed base as team member but as well as project manager.
Key requirements of the QC/Lab Head include:
- Minimum B.A. or B.S. degree in Life Sciences discipline or comparable education.
- Leadership experience paired with the ability to motivate and support the team.
- Sound experience in a Quality Control function, Certified Quality Manager or Quality Auditor preferred.
- Excellent knowledge of GMP, ISO 13485, 21 CFR 820 ideally in IVD environment.
- Several years of laboratory experience in context of QC testing and release processes.
- Knowledge in medical terminology, quality management, QC processes and international quality management regulations.
- Strong organizational skills as Manager to be able to work on challenging and resource critical projects.
- Competency to understand and assess processes and interfaces in and with other departments.
- Advanced knowledge of MS Office and Document Management Systems.
- High level communication skills written and spoken in English and German, French is a plus.
