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

Please use a modern web browser