Director, Clinical Quality Assurance

Role Summary

Director, Clinical Quality Assurance Compliance leading quality assurance activities across global clinical development programs with a proactive, risk-based quality strategy to ensure GCP compliance and foster a culture of quality within the Global Development Organization.

Responsibilities

• 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, and 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

Qualifications

Education

• 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
• Fluent in English (Mandarin is a plus)

Skills

• Quality Strategy Development
• GCP Compliance and Regulatory Inspection Readiness
• Risk-Based Quality Management
• Clinical Documentation Review
• Quality Agreements Management
• Leadership and Team Development

Education

• University degree in life sciences; advanced degree preferred

Additional Requirements

• Travel requirements not specified; adjust if applicable to role