Senior QM Manager
Berlin | Full-time
You will be responsible for the following tasks as an interface between the office location Knesebeckstrasse (Charlottenburg) and the laboratory location in Berlin-Buch:
- Administration and further development of the quality management system (QMS) of Berlin Cures GmbH for clinical and preclinical research according to the required quality standards (GCP, GMP, GCLP)
- Planning, implementation, control and monitoring of quality assurance activities in all departments
- Definition of activities regarding deviation and change management, and CAPA process
- Planning, execution and coordination of regular audits within Berlin Cures GmbH (self-inspections) as well as at contract partners' facilities
- Recording, investigation and evaluation of weak points as well as initiation and monitoring of corrective and/or improvement measures
- Planning and implementation of employee training and administration of training documentation
- Advising all departments on the importance and criticality of planned activities and recommending quality assurance measures
- Regular reporting to the management
- Participate in the preparation and approval of regulatory documentation
- Participation in the preparation of regulatory documents and clinical study documents
- Support clinical and preclinical project management
- Oversee calibration and maintenance of laboratory equipment
- Planning and execution of validation of computerized systems
- Preparation of study plans, amendments and study reports
- Data management and data integrity control
- Compilation of clinical and preclinical study data
Your qualification includes:
- Completed pharmaceutical or scientific studies or comparable training
- Qualification in quality management or several years of professional experience in a quality regulated environment
- Extensive knowledge of national and international regulations, laws and standards of the pharmaceutical industry as well as profound GCP knowledge
- Ideally practical experience in a diagnostic laboratory or knowledge of analytics
- Very good knowledge of German and English, both written and spoken
- Very good knowledge of MS Office (Word, Excel, Power Point)
- Enjoy working with figures and documents
- Critical, careful and foresighted way of working as well as very good organizational skills
- Ability to cooperate and assert yourself as well as a self-confident appearance
- Ability to work under pressure, flexibility and open-mindedness
We offer:
- Performance-related remuneration
- Opportunities and possibilities for personal and professional development
- Open and lively communication
- Diverse areas of responsibility with a high degree of independence and personal responsibility in a future-oriented company
- Interdisciplinary cooperation with colleagues in a small, highly motivated team
- Attractive working environment and very appealing office space in a central location
- Support in achieving a good work-life balance
If this sounds appealing to you, we look forward to receiving your detailed application, including your earliest possible starting date and your salary expectations.
Apply now