Associate Director Quality - Client Dedicated- Regional Clinical Compliance Inspection

General Description

The Associate Director Quality - Client Dedicated
- Regional Clinical Compliance Inspection is responsible for driving proactive risk management, sustained inspection readiness, audit support, and regulatory compliance across clinical trials. The role provides leadership and oversight to ensure consistent implementation of GCP and regulatory requirements, effective inspection readiness programs, and successful management of inspections and audits.

The Associate Director Quality - Client Dedicated
- Regional Clinical Compliance Inspection is responsible for driving proactive risk management, sustained inspection readiness, audit support, and regulatory compliance across clinical trials. The role provides leadership and oversight to ensure consistent implementation of GCP and regulatory requirements, effective inspection readiness programs, and successful management of inspections and audits.

Key responsibilities include leading inspection readiness and audit support activities at regional or global levels, guiding clinical teams on inspection expectations, coordinating audit and inspection responses, and ensuring timely, high-quality, and compliant remediation. The role also drives a proactive inspection/audit readiness culture, to effectively manage complex, high-risk inspections while maintaining continuous readiness.

• Organize briefing materials, logistics, and stakeholder alignment
• Support inspection readiness across the EMEA region
• Support implementation of standards, tools, and best practices
• Ensure teams are inspection-ready through training and guidance
• Assess inspection risks and oversee mitigation plans
• Supports mock inspections and readiness assessments
• Maintain inspection-ready documentation, processes, and systems
• Supports development of story boards based on global story boards templates and structure and acting as subject matter expert (SME) in content generation together with the relevant functional area SMEs

• Support regional preparation activities for regulatory inspections and internal/external audits
• Coordinate cross-functional stakeholders (Clinical Operations, QA, country teams)
• Align with Regional Clinical Compliance Lead to conduct targeted site preparation visits as required

• Lead and coordinate responses to inspection/audit findings
• Manage CAPAs, including risk assessment, root cause analysis, and effectiveness checks
• Track CAPAs to timely and effective closure
• Ensure robust root cause analysis and sustainable corrective actions
• Oversee CAPA strategies and regulatory commitments
• Drive consistent, high-quality organizational responses
• Monitor trends and identify opportunities for continuous improvement

• Understanding of clinical trial processes with a thorough knowledge of ICH-GCP and associated regulatory guidelines
• Analytical and problem-solving skills and high attention to detail, and quality orientation
• Excellent communication and stakeholder management skills
• Influence senior stakeholders and decision-making

• Excellent English written and verbal communication and interpersonal skills
• Excellent organizational skills and ability to prioritize and multi-task
• Ability to work independently in multi-cultural setting and effectively handle multiple priorities in a fast-paced environment

Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline
* with 10+ years in clinical research, clinical operations, or compliance.

Minimum 4 years’
** experience in a GCP compliance or equivalent role* (i.e. quality) is preferred.

• Experience in CAPA development and tracking
• Experience in inspections and audits management, including mock inspections and mock interviews
• Deep knowledge of ICH-GCP, regulatory requirements and Clinical trial processes end-to-end
• Experience in oncology global trials is preferred
• Requires deep knowledge of one or more related job areas typically obtained through advanced education…