Clinical FSP Director Quality - Client Dedicated- Regional Clinical Compliance Inspection Lead in Reading

Job Overview

The Clinical FSP Director Quality - Client Dedicated- Regional Clinical Compliance Inspection Lead 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.

Essential Functions

• Lead regional or global inspection readiness and audit support activities, guiding clinical teams on inspection expectations.
• Coordinate audit and inspection responses, ensuring timely, high‑quality, and compliant remediation.
• Develop and maintain inspection readiness standards, tools, frameworks, and best practices in partnership with Global Clinical Compliance and RDQA.
• Provide training, guidance, mock inspections, and readiness assessments to maintain inspection‑ready documentation, processes, and systems.
• Assess inspection risks, oversee mitigation plans, and maintain documentation that supports compliance.
• Coordinate inspection logistics, briefing materials, and stakeholder alignment across teams.
• Serve as senior escalation point and executive liaison during regulatory inspections and audits.
• Lead post‑inspection activities, including CAPA management, root‑cause analysis, trend monitoring, and continuous improvement.

Core Competencies, Knowledge And Skill Requirements

• Understanding of clinical trial processes with thorough knowledge of ICH‑GCP and associated regulatory guidelines.
• Excellent analytical, problem‑solving, quality management skills and high attention to detail.
• Strong communication, stakeholder management, and influencing skills, including senior leadership engagement.
• Demonstrated leadership in complex, global environments.

Communication & Interpersonal Skills

• Excellent English written and verbal communication and interpersonal skills.
• Excellent organizational skills and ability to prioritize and multitask.
• Ability to work independently in a multicultural setting and effectively handle multiple priorities in a fast‑paced environment.

Supervisory Responsibilities

• Serves as a GCP expert to the Clinical Operations EMEA with excellent working knowledge of ICH/GCP, regional regulations, SOPs, and Clinical Operations Work Instructions.
• Demonstrates a high level of clinical operations knowledge and strong analytical and managerial skills.
• Ensures appropriate escalation of quality issues, potential misconduct, and significant deviations to relevant stakeholders.

Qualifications

• Bachelor’s degree (BS/BA or equivalent) in a scientific, medical, or healthcare discipline.
• 12+ years in clinical research and clinical operations; minimum 6 years’ experience in a GCP compliance or equivalent role.
• Experience in CAPA development and tracking, inspections and audits, including mock inspections and mock interviews.
• Deep knowledge of ICH‑GCP, regulatory requirements, and end‑to‑end clinical trial processes.
• Experience in oncology global trials is preferred.
• Sound working knowledge of medical terminology, SOPs, GCP, FDA regulations, quality improvement initiatives and processes.
• Knowledge of national and international regulations and drug development process.
• Knowledge of CRO or pharmaceutical industry operations.
• Knowledge of IQVIA corporate standards and SOPs.
• Excellent organizational, interpersonal and communication skills.
• Excellent judgment and decision‑making skills.
• Excellent leadership and line management skills.
• Excellent influencing and negotiation skills.
• Strong computer skills, including Microsoft Office and clinical management applications.
• Excellent problem‑solving skills.
• Excellent ability to work in a matrix environment.
• Ability to lead and motivate a clinical team.
• Ability to travel extensively globally and within the region.
• Fluent in English.

Please note this role is not eligible for the UK VISA sponsorship.