Ansprechpartner
Nadja Küppers
+49 (0)89 7263 210 – 09
kueppers@ageneo.de
Branche
Pharmazeutische Industrie
Berufsfeld
QM
Region
Bavaria (Germany)

DAS UNTERNEHMEN

For a leading bio-pharmaceutical company in Bavaria, we are currently looking for a Head of Quality Management (m/f/d). In this role, you will be responsible for the internal quality management system in regards to analytics and quality control departments. If you want to become part of a growing company with a great culture, we should get in contact. 

IHRE AUFGABEN

  • Management and development of the internal QM team
  • Responsible for all internal quality processes
  • change control, deviations, training, review of analytical documents, internal audit, equipment qualification and validation of computerized systems, SOP management
  • continuous improvement of internal Quality Management System
  • Define and generate key performance indicators (KPI) and metrics and keep oversight and control on performance and efficiency of processes
  • Preparation of and lead in regulatory inspections and customer audits and ensure close follow-up of corresponding CAPA plans
  • Training and further education of the laboratory team on quality and data integrity standards including occupational health and safety

IHR PROFIL

  • Degree (master, diploma, PhD) in pharmacy, chemical engineering, biotechnology, or a related field
  • 5+ years’ experience in pharmaceutical QA and compliance functions with focus on analytical development and QC activities
  • Experience in data integrity requirements, equipment qualification and validation of computerized systems
  • Experience in FDA inspections would be a nice to have
  • Fluent in written and spoken English, good command of German

BENEFITS

  • Excellent work and company culture 
  • Flexibility and additional social benefits 
  • Working "in the heart" of Bavaria