Assoc Director, Quality Management - Client Dedicated Clinical Compliance Optimization Lead

Posted 2 Hours Ago
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18 Locations
In-Office or Remote
Expert/Leader
Healthtech
The Role
Lead detection and analysis of compliance signals and trends across EMEA, translate insights into risk patterns, and recommend process improvements. Partner with RBQM, Global Clinical Compliance, and operations to implement scalable quality and GCP-aligned changes, deliver training, and drive stakeholder adoption to improve clinical trial execution and consistency.
Summary Generated by Built In
Job Description Summary

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.
takeholder 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.

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.

Skills Required

  • Bachelor's degree in a scientific, medical, or healthcare discipline (BS/BA or equivalent)
  • 10+ years in clinical research and clinical operations
  • Minimum 4 years experience in 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)
  • Experience supporting or implementing global process changes
  • Experience in oncology global trials
  • Sound working knowledge of ICH, GCP, SOPs, applicable regulatory requirements, and quality management processes
  • Demonstrated leadership and line management skills
  • Excellent organizational, interpersonal, communication, judgement, influencing and negotiation skills
  • Strong computer skills including Microsoft Office applications
  • Ability to work in a matrix environment
  • Ability to lead and motivate a clinical team
  • Ability to travel within the region/country
  • Fluent in English

IQVIA Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IQVIA and has not been reviewed or approved by IQVIA.

  • Healthcare Strength Healthcare coverage is positioned as comprehensive, spanning medical/dental/vision plus programs like telemedicine, EAP resources, and additional insurance options. Feedback suggests the health offering is a meaningful part of the overall rewards package, though details can vary by location and plan design.
  • Retirement Support Retirement benefits include an employer match structure that supports employee contributions through a defined formula. This adds steady long-term value to total rewards beyond base salary.
  • Leave & Time Off Breadth Time off offerings include vacation/paid time off, holidays, and flexibility themes, with some roles described as having discretionary or unlimited time-off models. This can make the package feel more attractive even when cash compensation is viewed as only mid-range.

IQVIA Insights

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The Company
HQ: Durham, NC
61,500 Employees
Year Founded: 2016

What We Do

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise. IQVIA Connected Intelligence™ delivers powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 70,000 employees, IQVIA conducts operations in more than 100 countries. To learn more, visit www.iqvia.com.

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