Associate Director, Quality Management

Job summary

The Associate Director, Quality Management is tasked with identifying signals, trends, and systemic issues in clinical trial execution across the EMEA region to foster continuous improvement. This role involves translating operational insights into actionable strategies, collaborating with various teams to enhance compliance, efficiency, and quality.

Qualifications

• Bachelor's degree in a scientific, medical, or healthcare discipline or higher.
• Over 10 years of experience in clinical research and operations, with at least 4 years in GCP compliance or quality roles.
• Familiarity with RBQM principles and data-driven decision-making.
• Experience in process improvement and operational excellence initiatives.
• Certification in quality management or process improvement methodologies is a plus.
• Preferred experience in oncology global trials.
• Strong knowledge of ICH guidelines, GCP, SOPs, and regulatory requirements.
• Excellent organizational, communication, and leadership skills.
• Proficient in Microsoft Office applications.
• Fluent in English.

Responsibilities

• Analyze compliance data to identify trends and systemic issues.
• Report findings and recommendations to stakeholders for informed decision-making.
• Collaborate with RBQM teams to enhance risk assessment and mitigation strategies.
• Support process improvement initiatives at regional and country levels.
• Act as a liaison between regional teams and global compliance.
• Promote best practices across regions.

Skills

• Strong problem-solving and decision-making abilities.
• Excellent influencing and negotiation skills.
• Ability to work effectively in a matrix environment and lead clinical teams.
• Willingness to travel within the region.

Education

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

Tools

• Proficient in Microsoft Office applications.