Associate Director Quality (Clinical Compliance, On-site)

Job summary

The Associate Director Quality is tasked with leading proactive risk management and ensuring compliance across clinical trials. This role emphasizes maintaining inspection readiness and supporting audits while guiding clinical teams through regulatory expectations.

Qualifications

• Bachelor’s degree in a scientific, medical, or healthcare discipline.
• Over 10 years of experience in clinical research, clinical operations, or compliance.
• Minimum of 4 years in a GCP compliance or quality role preferred.
• Experience in CAPA development and management.
• Familiarity with ICH-GCP and regulatory requirements.

Responsibilities

• Lead inspection readiness and audit support activities at regional levels.
• Organize materials and logistics for inspections.
• Ensure teams are prepared through training and guidance.
• Coordinate responses to inspection findings and manage CAPAs.
• Monitor trends for continuous improvement.

Skills

• Strong analytical and problem-solving abilities.
• Excellent communication and stakeholder management skills.
• Ability to influence senior stakeholders.
• Proficient in Microsoft Office applications.

Education

• Bachelor’s degree or higher in a relevant field.

Tools

• Familiarity with quality management processes and relevant regulatory guidelines.