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Senior Director Quality Management, part-time or full-time (m/f/d)

Einsatzort: Hamburg

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Indivumed is a physician-led, integrated global oncology company for personalized medicine with the world's premier high-content tumor database and highest-quality biobank. Our range of services and products is tailored to customers' needs in translational and clinical research and molecular diagnostics. With approximately 200 employees across Europe, North America, and Asia, we are an internationally minded, future-oriented company with an ambitious growth strategy, which includes the development of a global cancer database solution. Indivumed is proud of our innovative team of leading scientists and of our strong international reputation. At Indivumed, you are given the rare opportunity to pursue your professional goals and benefit from quick decision processes - thanks to a flat organizational structure and ample creative freedom.

Senior Director Quality Management, part-time or full-time (m/f/d)

Skills and abilities

    Coordinating with all departmental Quality Managers all relevant quality management topics department, which include in detail:

  • Overseeing the maintenance and further development of the QM system according to ISO 9001:2015
  • Creation and administration of QM documentation
  • Planning and ensuring the performance of internal/external audits in cooperation with the departmental QM Managers
  • Implementation of corrective and preventive measures
  • Accompany and prepare new certifications of our subsidiaries (also in the US)
  • Organization and execution of management reviews
  • Staff training and advice on the QM system
  • Organization and implementation of quality circles
  • Information of the management about the overall state of quality assurance
  • Participation in the planning and further development of quality requirements
  • Quality assurance according to GCP/GCLP
  • Complaint management
  • Ensuring compliance with applicable guidelines and standards
  • Contact person for certification body
  • Management, motivation and further development of subordinate QM employees
  • Planning, execution and follow-up of external audits and follow-up of measures
  • Maintenance and further development of the QM system according to ISO 9001:2015
  • Support in the handling, administration and tracking of deviations and risks in the area of responsibility
  • Independent and target-oriented way of working
  • Strong organizational skills and reliability
  • Very good communication skills and ability to work in a team
  • Ability to work under pressure and assertiveness even in times of increased workloads

Education and/or experience

  • At least 5 years' experience in charge of a QMS, preferably in the life sciences industry
  • Experience with internal/external audits
  • Professional experience in the field of quality and process management as well as a sound knowledge of the Quality assurance and the current quality standards (especially DIN EN ISO 9001:2015)
  • Experience with GCP/GCLP is an advantage
  • Experience in risk management desirable
  • Fluent written and spoken in English and German
  • Willingness to travel occasionally

Working conditions

  • Demanding area of responsibility in a fast-growing company
  • Creative freedom
  • Short decision paths
  • A collegial team and a good working atmosphere
  • Continuing education and training
  • Support of occupational pension scheme
  • Grant for the HVV ProfiTicket
  • Subsidy for sports membership and events
  • Fresh fruits and drinks
  • Christmas and summer party
  • Company medical examination
  • Flexible working hours
  • Part-time work with 30-35 hours per week is possible
  • Optional home office