Clinical FSP Director Quality - Client Dedicated- Regional Clinical Compliance Inspection Lead
IQVIA
Clinical FSP Director Quality - Client Dedicated- Regional Clinical Compliance Inspection Lead
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. 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.
Clinical FSP Director Quality - Client Dedicated- Regional Clinical Compliance Inspection Lead
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. 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.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Preferred Qualifications
Technical (Nice-to-have)
Key Responsibilities
- 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
- 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
- Align 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
- 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
- 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
- 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