(Senior) Manager Clinical Quality Assurance (m/f/d)

Your Profile:

• You have a degree in natural sciences, medicine, quality management, or equivalent industry experience
  
• Minimum of 5 years of experience in working for life sciences companies in a clinical quality management function, preferably with FiH / phase I studies experience in biotech or sponsor organization
  
• In-depth knowledge of GCP regulatory requirements, knowledge in G(C)LP and GMP would be an advantage
  
• Advocate of quality by design with a speak-up mentality
  
• Ability to work in teams as well as in matrix organizations
  
• Ability to see the big picture of early development, using analytical reasoning and strong problem solving skills to provide phase and risk proportionate guideance
  
• Excellent communication skills in English and preferably in German

Your Tasks:

• Plan, conduct and report internal and external audits incl. communication of findings and recommendations to management and staff
  
• Support the team in developing appropriate corrective and preventive actions, where appropriate
  
• Perform risk management for projects and coordinate appropriate actions to assess and mitigate quality issues in collaboration with our project teams
  
• Improving quality or resolving a GxP deficiency and monitoring the implementation of CAPA
  
• Create, revise or review SOPs and quality related documents to ensure GxP Compliance and a risk-based approach to quality
  
• Support Head of QA in implementing a risk-based GxP Quality Management, risk management and audit planning
  
• Support the implementation and the maintenance of inspection readiness concepts and the preparation, hosting, and follow up of regulatory inspections
  
• Be an integral part of interdisciplinary project teams as quality advisor
  
• Organise and conduct quality related trainings to colleagues

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