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

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.
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.
This role is the main point of contact for inspection and audit management ensuring continuous communication with Global Clinical Compliance (GCC), enabling alignment and implementation of GCC strategies and initiatives within the EMEA region.


Essential Functions
Oversight of Inspection & Audit Portfolio
• Oversee high-risk and high-visibility inspections globally/regionally and Ensure consistency and quality
across inspection handling
• Provide directions for preparation, execution, and response
• Intervene in complex or critical inspection scenarios

Inspection readiness implementation and oversight

• Lead inspection readiness across the EMEA region, ensuring alignment with global compliance requirements
• Drive implementation of inspection readiness standards, tools, frameworks, and best practices in partnership with GCC and RDQA
• Aligning regional activities with global compliance requirements and drive implementation of standards, tools, and best practices
• Ensure inspection readiness through training, guidance, mock inspections, and readiness assessments
• Assess inspection risks, oversee mitigation plans, and maintain inspection-ready documentation, processes, and systems
• Develop and maintain regional storyboards aligned with global templates, providing SME support for
content development
• Coordinate inspection logistics, briefing materials, and stakeholder alignment

Inspection and Audit Preparation, Execution and Follow up
• Lead 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 where required

Inspection & Audit Execution Leadership
• Serve as the senior escalation point and executive liaison during regulatory inspections and audits
• Support senior-level engagement with regulatory authorities and ensure aligned messaging, risk positioning, and response strategies

Post-Inspection/Audit Activities
• Lead and coordinate responses to inspection/audit findings and ensure sustainable corrective actions and delivery of regulatory commitments
• Oversee CAPA management, including risk assessment, root cause analysis, effectiveness checks, and timely closure
• Monitor trends, drive continuous improvement, and strengthen inspection readiness through lessons learned and partner cross-functionally to promote consistent, high-quality inspection outcomes

Core Competencies, Knowledge and Skill Requirements:

• Understanding of clinical trial processes with a 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 multi-task
• Ability to work independently in multi-cultural 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) or higher in a scientific, medical or healthcare discipline* with 12+ years in clinical research, clinical operations, plus minimum 6 years’ experience in a GCP compliance or equivalent role* (i.e. quality) is preferred

• Experience in CAPA development and tracking, inspections and audits, including mock inspections and mock interviews including leading risk-based inspection preparation programs
• Deep knowledge of ICH-GCP, regulatory requirements and Clinical trial processes end-to-end
• Experience in oncology global trials is preferred
• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Food & Drug Administration (FDA) regulations, quality improvement initiatives and processes.
• Knowledge of National and International Regulations and Drug Development process.
• Knowledge of Clinical Research Organization (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 also required.
• Ability to travel extensively globally/ within the region.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Fluent in English.