Clinical Compliance Director (On-site)

Job summary

The Clinical Compliance Director is responsible for ensuring proactive risk management, sustained inspection readiness, and regulatory compliance across clinical trials. This role provides leadership and oversight for the implementation of Good Clinical Practice (GCP) and regulatory requirements, focusing on effective inspection readiness programs and management of audits.

Qualifications

• Bachelor’s degree in a scientific, medical, or healthcare discipline.
• 12+ years of experience in clinical research or operations, with a minimum of 6 years in a GCP compliance role.
• Experience in CAPA development, inspections, and audits, including mock inspections.
• Deep knowledge of ICH-GCP and clinical trial processes.
• Preferred experience in oncology global trials.

Responsibilities

• Oversee high-risk inspections globally and ensure quality across inspection handling.
• Lead inspection readiness initiatives across the EMEA region, aligning with global compliance requirements.
• Coordinate preparation activities for regulatory inspections and audits, engaging cross-functional stakeholders.
• Serve as the senior escalation point during inspections and audits, supporting engagement with regulatory authorities.
• Lead responses to inspection findings and ensure sustainable corrective actions.

Skills

• Strong analytical, problem-solving, and quality management skills.
• Excellent communication and stakeholder management abilities.
• Demonstrated leadership in complex, global environments.
• Ability to work independently in a multicultural setting and manage multiple priorities.

Education

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

Tools

• Proficient in Microsoft Office and Clinical Management applications.