Associate Director Quality (Clinical Compliance, On-site)

Job summary

The Regional Clinical Compliance Lead is tasked with overseeing a team of Clinical Compliance professionals, ensuring adherence to regulatory standards and operational excellence in clinical trials. This role emphasizes leadership, strategic alignment, and the promotion of a quality-focused culture.

Qualifications

• Bachelor’s degree in a scientific, medical, or healthcare discipline.
• Minimum of 8 years in clinical operations, with at least 6 years in GCP compliance or a similar role, including 4 years of people management experience.
• Preferred experience in oncology global trials.
• Deep understanding of ICH-GCP, regulatory requirements, and quality management processes.

Responsibilities

• Act as the main contact for compliance queries and provide expert guidance on regulations.
• Oversee inspection preparations and lead during audits.
• Ensure high-quality execution of compliance activities and monitor KPIs.
• Manage budget and resource allocation for compliance activities.
• Collaborate with senior leadership to align local execution with global compliance strategies.

Skills

• Strong analytical and problem-solving abilities.
• Excellent communication and stakeholder management skills.
• Ability to work independently in a multicultural environment.
• Proficient in Microsoft Office applications.

Education

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

Tools

• Familiarity with compliance-related software and tools is beneficial.