Director, Clinical Quality Assurance

• Lead quality assurance activities across clinical development programs in global teams
• 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.

Requirements

• University degree in life sciences; advanced degree preferred
• 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

Core Competencies

Demonstrates extensive expertise in GCP compliance and quality assurance within clinical development, with a strong focus on strategic risk management and team leadership. Proficient in developing quality strategies and ensuring inspection readiness across global clinical trials.

Highest-signal resume keywords

• GCP Compliance
• Quality Management
• Clinical Operations
• Regulatory Authority Inspections
• Team Leadership

ATS Optimization Keywords

Hard Skills

• Clinical Quality Strategy Development
• Risk-Based Quality Management
• CAPA Management
• Quality Agreement Management
• Inspection Readiness

Soft Skills

• Proactive Communication
• Team Development
• Collaboration

Industry Keywords

• GCP
• ICH
• FDA
• EMA
• MHRA

Tools & Technologies

• MS Office
• Electronic Quality Management Systems

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