Associate Director Quality Management

IQVIA•Durham, NC

About The Position

The Regional Clinical Compliance Lead leads, develops, and manages a team of Clinical Compliance professionals supporting country- and site-level oversight. The role combines people leadership with operational and strategic accountability to ensure consistent, high-quality execution of risk-based compliance activities. It builds team capability, drives performance, and aligns team activities with global compliance strategies while fostering quality, accountability, and continuous improvement. The role serves as the primary contact for the RCC country compliance managers team on GCP requirements, company and study-specific procedures, and compliance queries. It provides regulatory and internal-standard guidance; oversees inspection preparation, execution, and follow-up; supports high-impact audits and inspections; and ensures lessons learned are applied consistently. The position oversees risk-based compliance execution across countries and studies, monitors KPIs and quality trends, identifies systemic risks and improvement opportunities, escalates critical issues to the Head RCC EMEA, and drives effective CAPAs. It reviews remote compliance activities, risk strategies, and site-level assessments, and promotes standardized processes. It also manages budgets, resources, and workloads; supports workforce planning; translates global strategy into team objectives; partners with RCC, global compliance, clinical operations, and quality teams; and represents the function in governance forums. As a people leader, the role coaches and develops a regional team, sets expectations, conducts performance reviews, addresses skill gaps, supports talent management and succession planning, and fosters an inclusive, collaborative, high-performing environment. Travel within the region or country is required. This role is not eligible for UK visa sponsorship.

Requirements

Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical, or healthcare discipline.
Minimum 8 years of progressive experience in clinical operations roles.
Minimum 6 years of experience in a GCP compliance or equivalent quality role, including people management experience.
Minimum 4 years of people management experience.
Thorough knowledge of clinical trial processes, ICH-GCP, and associated regulatory guidelines.
Sound working knowledge of relevant terminology, ICH, GCP, SOPs, applicable regulatory requirements, and quality management processes.
Excellent organizational, interpersonal, written and verbal communication, and stakeholder-management skills.
Excellent judgment and decision-making skills.
Demonstrated leadership, line management, influencing, and negotiation skills.
Strong computer skills, including Microsoft Office applications.
Excellent analytical, problem-solving, and attention-to-detail skills, with a quality orientation.
Demonstrated ability to work in a matrix environment and lead and motivate a clinical team.
Ability to work independently in a multicultural setting, prioritize and multitask, and handle multiple priorities in a fast-paced environment.
Ability to establish and maintain effective working relationships with co-workers, managers, and clients.
Fluent in English.
Ability to travel within the region or country.

Nice To Haves

Experience in oncology global trials is preferred.
Deep knowledge of one or more related job areas, typically obtained through advanced education combined with experience.

Responsibilities

Serve as the primary contact for the RCC country compliance managers team on GCP requirements, company and study-specific procedures, and general compliance queries.
Provide expert interpretation of regulations and internal standards to support consistent compliant practices.
Oversee preparation, execution, and follow-up for inspections, and provide leadership support during high-impact audits and inspections.
Ensure lessons learned are applied consistently across the team.
Ensure consistent, high-quality execution of risk-based compliance activities across countries and studies.
Monitor KPIs, quality metrics, and compliance trends; identify systemic risks, recurring issues, and opportunities for improvement.
Escalate critical compliance issues to Head RCC EMEA and ensure effective resolution.
Drive accountability for CAPA quality and effectiveness.
Provide oversight and quality review of remote compliance activities, risk identification and mitigation strategies, and site-level compliance assessments.
Drive standardization and harmonization of team processes.
Manage the budget, resource allocation, and workload balancing according to the study portfolio and risk profile.
Ensure appropriate resourcing for high-risk studies, sites, and compliance activities; partner with senior leadership on workforce planning and capability needs.
Translate global compliance strategies into team-level objectives and actions.
Partner with RCC Inspection and Audit Lead, RCC Process Excellence and Risk Surveillance, Global Clinical Compliance, Clinical Operations leadership, and Quality Assurance teams.
Represent the function in governance forums and cross-functional discussions.
Lead, coach, and develop Regional Clinical Compliance professionals across multiple countries; set performance expectations and conduct regular performance reviews.
Identify skill gaps and implement targeted development plans; drive talent management, succession planning, and retention of key talent.
Foster an inclusive, collaborative, high-performing team culture focused on quality, accountability, continuous improvement, psychological safety, feedback, innovation, and learning.
Model ethical behavior and reinforce a compliance mindset across the team.
Travel within the region or country as required.