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

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

Responsible for proactively identifying signals, trends, and systemic issues across countries and the EMEA region to drive continuous improvement in clinical trial execution and processes. The role translates 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 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.

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) in a scientific, medical or healthcare discipline with 10+ years in clinical research, clinical operations, plus minimum 4 years of 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) 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.