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.

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.

Inspection readiness implementation and oversight
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

Inspection and Audit Preparation Execution and Follow up
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

Post-Inspection/Audit Activities
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

Core Competencies Knowledge and Skill Requirements:

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

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


Qualifications
Bachelors 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 combined with experience.
Sound working knowledge of relevant terminology International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Standard Operating Procedures (SOPs) applicable regulatory requirements quality management processes.
Excellent organizational interpersonal and communication skills.
Excellent judgement and decision-making skills.
Demonstrated leadership and line management skills.
Excellent influencing and negotiation skills.
Strong computer skills including Microsoft Office applications.
Excellent problem-solving skills.
Demonstrated ability to work in a matrix environment.
Ability to lead and motivate a clinical team also required.
Ability to travel within the region/country.
Ability to establish and maintain effective working relationships with co-workers managers and clients.
Fluent in English.

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

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.