Director, Clinical Quality Assurance (m/f/d)

Your Qualifications:

• University degree in life sciences; advanced degree preferred
  
• Experience
  
• Profound professional experience (beyond 10 years) in a GCP-regulated environment
  
• Strong GCP expertise gained in a senior Quality Management and / or Clinical Operations role.
  
• Strategic and Risk-based mindset with experience developing quality strategies at program level
  
• Solid understanding of global clinical regulations and guidelines (ICH, FDA, EMA, MHRA)
  
• Experience in team leadership and development (in the GCP environment preferred)
  
• Experience in managing, hosting or supporting regulatory authority inspections (EMA/FDA/MHRA)
  
• Proficiency in MS Office and electronic quality management systems

Your Tasks:

• Develop and implement a proactive, risk-based Clinical Quality Strategy for assigned high-priority trials or programs, ensuring inspection readiness and GCP compliance
  
• Collaborate with internal teams, collaboration partners as well as external vendors (e.g. CROs) to identify, investigate, and remediate clinical trial risks and quality issues, including CAPAs and effectiveness checks
  
• Actively contribute to Clinical Trial teams by providing quality guidance and reviewing key study documentation
  
• Enable continuous inspection readiness and compliance with GCP, regulatory requirements, and internal
  
• standards
  
• Lead or support inspection preparation, facilitation, and follow-up activities
  
• Review and manage Quality Agreements with CROs and other vendors, ensuring compliance with agreed standards
  
• Lead and develop a team, fostering transparency and proactive communication
  
• Drive a culture of quality and continuous improvement across the Global Development Organization, including authoring and reviewing clinical quality procedures.
  
• Acting as an ambassador for quality: ensuring that quality is an enabler of delivery.

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