1 day ago

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

IQVIA

Amsterdam

1 day ago

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Assoc Director, Quality Management - Client Dedicated Clinical Compliance Optimization Lead responsible for identifying signals, trends, and systemic issues across EMEA to drive continuous improvement in clinical trial execution. Requires 10+ years in clinical research with 4+ years in GCP compliance or quality. Remote position based in Amsterdam.

RemoteFull-timeDirectorGCPICH

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

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RemoteFull-timeDirectorGCP

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Experience Required

10 years

Employment Type

Full-time

Experience Level

10+ years in clinical research, plus minimum 4 years in GCP compliance or GCP quality

Core Qualifications

Technical (Must-have)

GCPICHSOPsregulatory requirementsquality managementRBQMrisk identificationdata-driven decision-makingprocess improvementoperational excellenceMicrosoft Officeclinical researchclinical operationscomplianceaudit

Soft Skills

organizational skillsinterpersonal skillscommunication skillsjudgementdecision-makingleadershipline managementinfluencingnegotiationproblem-solvingability to work in matrix environmentability to lead and motivate a clinical teamability to establish and maintain effective working relationships

Preferred Qualifications

Technical (Nice-to-have)

Lean Six Sigmaoncology global trials

Key Responsibilities

•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.
•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 educational sessions within the EMEA region.
•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.
•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.

Assoc DirectorQuality ManagementClinical ComplianceEMEAGCPRBQMRemoteFull-timeIQVIAClinical Research

Core Qualifications

Technical (Must-have)

Soft Skills

Key Responsibilities

•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.

•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 educational sessions within the EMEA region.

•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.

•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.