IQVIA
Assoc Director, Quality Management - Client Dedicated Clinical Compliance Optimization Lead
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Job Description Summary
Assoc Director, Quality Management - Client Dedicated Clinical Compliance Optimization Lead
Assoc Director, Quality Management - Client Dedicated Clinical Compliance Optimization Lead is responsible for proactively identifying signals, trends, and systemic issues across countries and EMEA region to drive continuous improvement in clinical trial execution and processes. This role plays a key part in translating operational insights into actionable improvements, partnering with Global Clinical Compliance, RBQM (Risk-Based Quality Management), and global process owners to enhance efficiency, compliance, and quality across the organization.
Essential Functions Of The Job
Signal Detection & Trend Analysis
- Identify and analyze signals, trends, and systemic issues across EMEA using compliance-generated data, audit findings, inspection outcomes, and operational insights.
- Translate aggregated insights into meaningful risk patterns and improvement opportunities.
- Provide regular reporting and recommendations to stakeholders to support informed decision-making.
Process Improvement & Risk Management
- Propose and support process improvements based on identified trends and systemic issues.
- Collaborate closely with RBQM teams to integrate findings into process risk assessment and risk mitigation strategies.
- Ensure alignment of improvements with GCP requirements, company procedures, and quality standards
- Identify areas of additional training and support for preparing and delivering such educational sessions within the EMEA region.
Operational Excellence & Implementation
- Support regional and country-level process improvement initiatives to enhance efficiency, compliance, and consistency.
- Act as a liaison between regional/country teams and Global Clinical Compliance and global process owners.
- Facilitate the regional implementation of improvements identified at global, local or regional levels, ensuring scalability and sustainability.
- Promote best practice sharing across countries and regions.
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Stakeholder Collaboration & Influence
- Partner cross-functionally with Clinical Operations, Quality Assurance, RBQM, and Global Compliance teams.
- Influence stakeholders at multiple levels to drive the adoption of process enhancements.
- Support change management activities related to new or updated processes.
Qualifications
- Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline* with 10+ years in clinical research, clinical operations, plus minimum 4 years *experience in a GCP compliance or GCP quality.
- Experience with RBQM principles, risk identification, and data-driven decision-making.
- Experience in process improvement, operational excellence, or quality initiatives.
- Certification in quality management, clinical research, or process improvement methodologies (e.g., Lean Six Sigma) will be a plus.
- Experience supporting or implementing global process changes.
- 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.
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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 https://jobs.iqvia.com
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.
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